Automation Engineer/Technician

Mirus Consulting Group Manati , PR 00674

Posted Yesterday

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REQUIREMENTS:The summary of the experience and qualifications required for the position whether if the resource is an Engineer or a technician:

Associate Degree in Electronics/electro-mechanic or related technical fields, or Bachelors Degree in Engineering, Electronics or Computer.
This resource will support the Packaging and Inspection area and will support the control systems maintenance activities, spare parts and day-to-day technical support activities.
Two (2) years of working experience within an industrial environment with at least one (1) year of relevant combined experience in programmable logic controllers and production maintenance function within a pharmaceutical manufacturing plant.
High degree experience in Rockwell Automation platforms (Controllogix PLCs, Factory Talk HMIs, communication protocols) is required.
Siemens systems knowledge preferred.
High degree knowledge and experience in troubleshooting activities on control systems and manufacturing equipment.
Knowledge of mechanical concepts, electrical controls theory and electronic circuitry.
Capable to read and interpret complex electronic/electrical drawings and specifications.
Knowledge and experience in computer systems software/hardware. Capable to understand and use computers and software packages.
Capable to troubleshoot problems for highly technical equipment and instrumentation.
Knowledge of CGMPs, local/federal regulatory requirements and documentation procedures pertaining to pharmaceutical manufacturing plant.
Experience in the development of preventive/corrective maintenance to all facilities, utilities and operations equipment.
Experience in supporting qualification activities from an automation point of view.
High degree experience in troubleshooting of programmable logic controllers and ladder logic programs and, repairs pneumatic, electric and electronic instrumentation.
Bilingual English/Spanish, both written and verbal are required.
Able to interact effectively with people to establish and maintain excellent working relationship with internal and external customers at all organizational levels and disciplines in such a way to facilitate the validation/qualification work.
Able to plan and prioritize multiple complex activities simultaneously (i.e., installation, integration, commissioning and validations/qualifications, timelines, etc.) by using sound Project Management Skills.
Effective written and oral communication skills.
Customer service oriented and self-starter.
Ability to exercise good judgment.

SHIFT:

The resource must be willing to work on third shift and over the weekend period.

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Lyophilization Manufacturing Technician

Bristol Myers Squibb

Posted 2 months ago

VIEW JOBS At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. PRINCIPAL OBJECTIVE OF POSITION: To perform all the activities related to the Lyophilization processes for the parenteral manufacturing operations (Par Lyo & Parenteral Vials /PVA). In addition the incumbent monitors and performs activities related with the Environmental Control System and the Water for Injection System (WFI) with others departments. This position must comply with all Security guidelines, Environmental Health and safety regulations and the current Good Manufacturing Practices required by the job function. MAJOR DUTIES AND RESPONSIBILITIES: 1. Performs daily monitoring and operation of Parenteral Lyophilization manufacturing equipment in addition, coordinates, checks and verifies, calibration and, reports any equipment malfunctions to the production and maintenance supervisor. * Operates and monitors computerized systems Freeze Dryers (this include but is not limited to Filter Integrity tests, Clean in Place (CIP), Sterilization in Place (SIP), and Leak Tests (Vacuum Leak Rate and Bellows Tests). * Monitors Par Lyo and PVA areas environmental conditions (such as temperature, humidity and differential pressure) and; the utilities systems (such as Water for Injection (WFI) and the steam generator that support the Parenteral Lyophilization Area and others departments). 2. Ensures that area documentation is complete following good documentation practices: * Initiates work orders, document revision, quality events, SAP transactions, etc. * Fills, organizes and audit production documentation and maintains Manufacturing Batch Record, logbooks and other documentation complete. * Revises and improve procedures and develops new SOPs based on observations, experiences and CAPA's. * Reconciles data and prepare computerized documents to provide support to quality investigations or similar documents as required. * Follows up progress of activities (e.g. documentation approval) with the support departments and inform status to supervision as requested. 3. Maintains housekeeping within controls and aseptic environments, according to procedures and Handles area Hazardous and Non-hazardous waste according to EHS procedures. Also performs WFI System loops and tanks sanitization, with the utilities personnel assistance. 4. Supports and Participates in the following activities: Participates, and assists in resolution of quality investigations. * Supports on troubleshooting activities, suggests solutions and actively participates in problem solving process. * Monitors formulation process in the PAS (Process Automation System) as required. * Supports Environmental Monitoring Program and Annual Requalification Program. * Participates in special projects, during audits and regulatory inspections. * Assists in Parenteral Operations validation and qualification activities and in manufacturing activities in other areas within operations as required. * Assists in "on the job training" for new employees. * Provides support during external, internal and regulatory audits. 5. Attends to all mandatory training meetings for cGMP's, EHS and Company Policies. KNOWLEDGE/ EDUCATION/ EXPERIENCE: * High School diploma with Five (5) years of experience in a Pharmaceutical industry including two (2) years of experience in Lyophilization process or Technical Degree in Refrigeration, Electronic or Instrumentation with One (1) year of experience in a Pharmaceutical industry including at least one (1) year of experience in Lyophilization processes and /or biotechnology processes. * Ability to reconciles and interprets data from Lyophilization cycles, and provide support for quality investigations related with cycles. * Ability to generate additional area process reports requested by internal and/or external customers. Develop and maintain area performance metrics. * Ability to troubleshoot area problems and generate Work orders * Willing to learn new equipment procedures and processes and train others operators. * Ability to maintain housekeeping and handles waste according to procedures. Revise current procedures and develop new SOP's. * Ability to provide job training (theoretical and/or On the Job) for new employees following the Parenteral Operations Department Qualification Curriculum. * Ability to maintain daily production and labor data in computerized system. * Ability to follows the daily production schedules. * Willing to work irregular hours, rotative shifts, weekends and holidays when necessary INITIATIVE AND INGENUITY: * Identify basic issues and problems. * Base his/her judgment on reasonable assumptions and thorough analysis of available information. * Learn from success and failures. * React to issues and addresses immediate problems as they arise and try to bring them to closure. * Resolve day-to-day problems that arise, generates alternatives and evaluates risk vs. benefits aligning personal, team and/or departmental activities with organizational goals and business strategies. * Foresees how decisions may impact the rest of the organization. * Negotiate and resolves issues that impact not only the Parenteral Lyophilization areas, but also those that affect other operations of the manufacturing site. * Comply with federal and local regulatory agencies (e.g., OSHA, EPA, FDA, DEA, etc). * Notifies immediate supervisor of any inconsistencies or violations to Company operation procedures and policies. PHYSICAL DEMANDS: 1. Adjust controls and equipment. Clean work area. 2. Climb stairs and ladders. 3. Connect cables and plugs. 4. Typical working conditions: 50 - 90% standing/walking, 10% sitting 5. Open doors and boxes. 6. Sort product and materials. 7. Use keyboard and computer or terminal to enter data. 8. Able to execute satisfactorily the hands scrubbing and gowning procedures. 9. Able to wear sterile gowns and mask while working inside the Aseptic Area. 10. Heavy work (25-60 pounds) that requires eye - hand coordination and moving about capacity. 11. Requires movements of objects such as lifting, carrying, pushing and pulling. It involves body movements such as handling and fingering. 12. Ability to operate pallet jacks. MENTAL AND VISUAL DEMAND: * Requires good concentration during the different manufacturing operations. * The incumbent will need to work under pressure and maintain concentration and composure. * Able to prevent and detect discrepancy during the manufacturing process. RESPONSIBILITY FOR EQUIPMENT OR PROCESS: * Follow internal procedures for each process or equipment in the area are critical to avoid product loss. * Not following the established procedures could impact the quality of the process RESPONSIBILITY FOR MATERIALS OR PRODUCTS: * Follows internal procedures when handling material or product and verifies that the manufacturing processes are mandatory to avoid product / material loss. RESPONSIBILITY FOR SAFETY OF OTHERS: * Does not have responsibility for Safety of other fellow employees but as a team player should assure that safety procedures and guidelines are followed within his/her area responsibility. * Provide guidance and direction to any fellow employee that is not following established safety rules RESPONSIBILITY FOR WORK OF OTHERS: * This job doesn't have responsibility for the work of others WORKING CONDITIONS: 1. The use of: hair covers, gloves, overall suits, dusk masks, air hoods, ear protection, helmet, etc. for personal and product safety are required accordingly to area that was assigned. 2. The use of: Uniform, Hair covers, beard cover, safety glasses, gloves, coverall suits, dust masks, etc. for personal and product safety are required accordingly to area that was assigned. 3. The incumbent must be trained in waste management disposable procedures. HAZARDS: * The employee may be required to properly handle and dispose of potentially dangerous, regulated hazardous materials or wastes into a designated on-site disposal facility or interim storage container. * A potential exposure to hazardous chemical substances during plant work. Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Documentation Technician

Bristol Myers Squibb

Posted 2 months ago

VIEW JOBS Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis. Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results. Summary: To provide administrative support related to the filing, handling and custodian of all Manatí site documents related to the manufacturing process through distribution of pharmaceutical products in a way that complies and ensures compliance with regulatory commitments, Federal and local regulations and Manatí site quality standards. The incumbent must comply with Corporate and HR Policies, FDA, GMP, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function. Responsibilities: 1. Administers document workflow through electronic document management system (creates, reviews, proofreads and distributes official documents (e.g., SOP's, WFP's, WPP, Monographs) both on and off-sites including the electronic document management system account maintenance, configuration changes, and data change requests. 2. Supports operational areas in maintaining proper documentation according to current SOP's, follows-up on SOP's pending periodic review and provides support to site projects. 3. Files and maintains vital documents and historical records (e.g. superseded SOP's, etc.) according to current Records Retention Policy. 4. Provides copies of documents as requested to other sites (e.g. reference, documents, drafts, etc.). 5. Issues official documents of Manufacturing, Packaging and Inspection with controlled lot numbers provided by the Materials Control Department. 6. Assists and provides training to Manatí personnel in electronic document management system related issues and in the implementation of new initiatives. 7. Verifies the area has consistency with other site procedures and/or specifications added to Purpose. 8. Provides compliance oversight and verifying compliance with BMS Policies, guidelines and regulations 9. Supports the Compliance Manager by providing the corresponding information to assure that all the Compliance personnel are qualified and trained in the applicable procedure required for their jobs functions. Knowledge/Skill: * Bachelor Degree * Two (2) years experience in a pharmaceutical industry manufacturing environment * Knowledge of cGMPs, OSHA, local, International and Federal regulatory requirements, and documentation procedures * Excellent Communications skills * Strong oral and written communication in English and Spanish is a must. Able to communicate effectively with internal and external customer * Self-starter with strong self-management skills: able to act with integrity, demonstrates adaptability and self-development * Good analytical skills * Ability to audit documents from other areas and take corrective action as necessary * Good Interpersonal and leadership skills * Working knowledge of office equipment such as PCs (Words, Excel, and Power Point), copiers, shredders, and fax machines * Ability to prioritize time to accomplish multiple tasks simultaneously according to Company needs * General knowledge of product manufacturing and packaging processes is a must * Ability to create complex forms using computer software packages (Microsoft Office) is a must Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

IT Operations Support Specialist

Bristol Myers Squibb

Posted 2 months ago

VIEW JOBS At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Accountable for providing operational IT support on computerized systems in the Manufacturing, Laboratories/QA, Facilities and Utilities areas including the monitoring and management execution of operational site mission critical systems (like: Syncade, Delta V, Laboratories Information Management System, Empower-Chromatographic Data System, Non-Chromatography Data Systems, Network, Communication Devices and stand alone computers). Also accountable for leading the validation team in the design, development and execution of validation plans and protocols for the systems in scope. This position must comply with all Security guidelines, Environmental, Health and Safety regulations and the current Good Manufacturing Practices required by the job function Responsibilities: * Supports Bristol-Myers Squibb manufacturing facility to ensure that cGMP's related IT Systems are properly maintained in accordance to all Federal, State and Corporate Regulations and therefore, supporting BMS's business goals. * Provides technical support to critical systems, like Syncade, Delta V, Empower-Chromatographic Data System, LIMs and others, to assure continuous operations of these computerized systems focused on systems users support. This includes configuration or programming and ongoing maintenance. * Works with the site's Manufacturing, Engineering and Quality Operations Management in the assessment, recommendation, validation, implementation and administration of the Computerized Systems. * Coordinates with Suppliers of hardware/software and services to obtain quotes, ordering parts and repairs. * Develops validation documentation of computerized system (such as validation plans, protocols, procedures, etc.), performs site periodic review of computerized systems validation evaluation and coordinates and performs activities as per approved Validation Plans and Protocols. * Administrates, maintains and executes change control activities related to Quality Systems. * Advises the IT Site Management on the adequacy/completeness of Qualification Protocols for approval. * Generates and maintains the related Standard Operating Procedures and perform required system maintenance activities. * Administers on a day-to-day basis the network/systems environment, such as: (1) Add, delete, modify users; (2) add, delete, modify printers and print jobs; (3) verify, create and restore backups; (4) add/remove PCs on the LAN; (5) security administration including granting of file/directory permissions; (6) performance monitoring (7) Database optimization and analysis. * Provides ongoing training to users on procedures, protocols and computer systems. * Works with IT Management and the site's Management in the assessment, recommendation, validation, implementation and administration of the Computerized Systems. * Recommends acceptance of the computer system, as determined from the tests performed on the Protocol and analyzes data in order to determine acceptability. * Recommends actions to be taken if the system is not accepted. * Generates Final/Validation Report in accordance with actual FDA concepts. * Provides assessment, recommendation, implementation, validation, troubleshooting and system administration of computerized systems. * Generates and/or executes and recommends action(s) to be taken whenever additions, alterations or changes are to take place in computerized systems. * Installation, configuration, qualification and maintenance of Systems servers including Operating System and Applications. * Coordinates and executes the installation, maintenance, qualification, validation and upgrade of the new and existing quality systems. * Supports the validation team in the design, development and execution of validation plans and protocols for the systems in scope. * Supports any system related Quality Event Investigation in alignment with corporate directives and Site procedures. * Performs process analysis and recommends improvements to existing processes and participates proactively as a team member of implementation projects for new integrated business application and process automation in equipment such as Building Automation System, Delta V, Factory Talk, SCADA Systems and General PLC's, providing consulting advice in the use and management of technology. * Evaluates and closes change control documentation assuring the validated and compliance state of the environments. Knowledge/Skills: * BS in Science, Computer/Information Technology or Engineering * Three (3) years experience in a pharmaceutical operations or Manufacturing processes environment * Two (2) years experience in process automation or laboratory systems * Two (2) years experience in computerized systems validation * In-depth knowledge of the science and computerized systems involved in the design, installation, commissioning and validation/qualification of computerized systems as applied to pharmaceutical production environment * Proficient knowledge of computer system development life cycle concepts, change control systems and FDA and EMEA regulatory requirements, including 21 CFR Part 11 * Proven experience issuing and preparing Computerized Functional Requirements and Design Specifications * Experience with external and internal regulatory audits * Experience in the design, development and implementation of infrastructure, MES and Quality Systems * General knowledge in applications such as: Maximo CMMS, TrackWise QMS, DCA DMS, Data Historian and laboratory systems * Ability to manage and operate computer software packages used for data acquisition systems and PLC programming * Skilled with Microsoft operating systems and MS Office applications * Knowledge of Computerized Equipment/Operating Systems: Client Server environment, Windows, Relational Databases: Oracle, SQL, etc. * Knowledge of SAP/R3 highly desirable * Excellent communication skills (oral, written and reading) in Spanish and English * Able to interact effectively with people to establish and maintain excellent working relationships with internal and external customers at all organizational levels and disciplines in such a way to facilitate the assigned work * The position requires working 2nd, 3rd or weekend shifts per business needs. Must be willing to work flexible hours, changing shifts (rotational work shifts), nights and weekends as required per business needs. * Self-starter and well organized. Ability to keep work pace and/or meet deadlines Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Apply