Manufacturing Process Engineer (3Rd Shift)

Pfizer Sanford , FL 32771

Posted 2 months ago

Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.

What You Will Achieve

You will be part of Pfizer's manufacturing division and support production, business, and other processes in a team-based environment. You will be performing activities in a variety of cross-functional areas, including support of production planning and control, total quality management, systems, manufacturing, equipment and facilities engineering, material management, and process reengineering.

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in solving difficult issues between teams and help in establishing consensus.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

  • Identify, execute and support continuous improvement opportunities and projects.

  • Perform lab qualification work & technical justification for new raw materials.

  • Provide Subject Matter Expert support during major investigations.

  • Trouble-shoot and provide sustainable solutions for root-cause processing and safety problems.

  • Support plant process change overs and plant clean ups.

  • Effectively use the site business processes to support production e.g. change control, deviations, six sigma method investigations, etc.

  • Ensure alignment between the process, the plant, the automation and process operators to run processes per Process Safety and Product Quality attributes and share best practices with teams.

  • Adhere to appropriate levels of current Good Manufacturing Practices (cGMP).

  • Responsible for product knowledge management during tech transfer into the site and during manufacturing campaigns.

  • Use computer-based modelling, simulation and analysis to look for improvement opportunities and to analyze problems.

  • Work to implement a culture of Right-First Time through partnerships with Operations and provide leadership in the use of Operational Excellence (OE) principles to optimize our technical and business processes.

Qualifications

Must-Have

  • Bachelor's Degree

  • 3+ years' experience

  • Demonstrated ability to provide technical solutions for complex problems through product and process knowledge

  • Good understanding of process manufacturing/ computer systems

  • Demonstrated ability to lead change and strong collaborative skills

  • Proactive and effective communication within and across shifts

  • Excellent mentoring and interpersonal skills

Nice-to-Have

  • Master's degree

  • Relevant pharmaceutical industry experience

PHYSICAL/MENTAL REQUIREMENTS

Capable of sitting and/or standing for extended periods of time during the work shift.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

12 hour shift (6 pm to 6 am) supporting 24/7 operations with the possibility of varying shift hours. Ability to operate in a classified area.

Other Job Details:

  • Last Date to Apply for Job: September 14th, 2021

  • Referral Bonus Eligible

  • NOT Eligible for Relocation Package

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Manufacturing

#LI-PFE

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Process Technology Manager Gene Therapy Drug Product

Pfizer

Posted 1 week ago

VIEW JOBS 10/13/2021 12:00:00 AM 2022-01-11T00:00 Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them. What You Will Achieve In joining the Pfizer team, you will have a key role in leveraging your substantive experience and knowledge to troubleshoot and solve on site problems. Your will partner with site operations managers and operations specialists to ensure that the sites and teams are in continuous state of audit readiness. You will have the responsibility for identifying areas of high risk and proactively implementing improvements, interfacing with site engineering, maintenance/calibrations, and technical operations to implement facility and process improvements, and managing overall changes in the area. As a Manager, you will provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes, or services. Through your comprehensive knowledge of principles, concepts, and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It Role Summary Works as part of a team to perform scientific, operational and process engineering tasks as they relate to technology transfer, scale-up operations, capital projects and routine manufacturing support. Must have the cross-functional scientific ability/skills/knowledge to lead process engineering efforts in the Drug Product area. Quickly adapts to cross-functional training as needed to advance pipeline projects. Works with minimal direct supervision and is responsible for leading and executing the design, optimization, implementation, troubleshooting, scale-up, tracking and reporting of a variety of drug product manufacturing processes. The incumbent must also comply with applicable safety, occupational health, loss prevention and environmental requirements. Serves as the technical lead of technology transfer and process/equipment design projects, interfaces directly as the point-of-contact for technical issues with sending site customers and solicits feedback and technical insight from fellow group members. Role Responsibilities Participate in clinical product tech transfer, production, and capital projects in a technical leadership capacity. Perform technical transfer and process engineering activities with minimal supervision to implement processes in the manufacturing areas. This may include leading and/or assisting in technical transfer of processes from development laboratories and small-scale pilot areas into the clinical production areas, as well as technical transfer from clinical to commercial facilities. This includes the following: * Provide lead process engineering knowledge and execution in process design from initial design specifications through implementation including testing during engineering projects. Collaborating with the Site, Engineering & Maintenance (SEM) department and/or outside engineering firm personnel will be critical to successful outcomes. Lead procurement of process equipment. Develop process flow diagrams for illustrating critical process and material flow. * Review, recommend and execute process improvements and optimizations to existing processes with engineering principles (e.g. cycle time reduction, equipment efficiency, PAT). Analyze root causes of process problems including but not limited to equipment failure, instrument malfunction, automation changes, and recommend technical solutions. Develops guides and executes implementation ofsolutions to complex process engineering problems. * Serves as the technical lead for technology transfer projects by serving as the point of contact with internal and external sending site customers. Ensures relevant technical information is relayed to group members and manufacturing colleagues, and solicits these personnel for feedback and improvement. Works with manufacturing to ensure readiness prior to the start of a production campaign. * Understand and provide input to the development of detailed process flow diagrams and step-by-step process fits of unit operations. Create, edit and maintain SOPs, Master Batch Records and Compounding Records needed for new projects within the approved QA document management system. Lead the revision process of documents as they evolve during the technical transfer and development process. Track approval of new and revised documents through the QA document approval process. * Collaborate with development personnel during engineering practice runs to introduce a variety of product candidate processes into clinical production areas through effective process scale-up and troubleshooting activities. This includes adjusting process parameters as necessary during engineering runs and pursuit of any necessary equipment/automation refinements to ensure optimized process performance prior to demonstration runs. Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, Master Batch Records and Compounding Records. Provide suggestions for innovative approaches to scale-up issues related to new projects. Incumbent is aware of new process parameters co-developed with colleagues and is able to introduce them into the process with area champion or supervisor input. * Maintain careful and accurate records of process and analytical data and findings on development projects. Utilize data and findings to contribute to meetings and make presentations on specific process issues. Provide observations/comments during schedule planning and process development meetings. During demonstration and clinical production campaigns, the incumbent will function as the process subject matter expert and will execute batch production and provide leadership to the manufacturing teams. The incumbent will also perform real-time troubleshooting of equipment and process operations to ensure successful batch completion. Additionally: * Coordinates the development and execution of studies to identify, resolve and/or correct manufacturing problems or process improvements, producing reports to substantiate findings, and establish validation acceptance criteria. * Participates in all internal and external audits related to validation activities. * Takes a leadership role in cross-functional teams to resolve problems to optimize output, minimize contamination, and minimize cost. * Provide effective leadership and direction to process engineering and operations personnel; build and develop talent and work with the regional/global teams to ensure key talent is developed across locations/businesses. * Support and enhance the technical capability of the manufacturing environment including process control and improvement. Implement process control and reporting tools to ensure process trends are reviewed in a timely manner. * Interact with Manufacturing Operations, Engineering and Product Development groups to proactively assess people/facilities' capabilities and capacity. * Ensure consistency of application of validation concepts across the site and the network. * Accountable for ongoing compliance of all process and cleaning validation activities with cGMP requirements. * Provide day-to-day support for technical issues in Mfg. Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the Clinical Manufacturing department. Adhere to site SOPs and cGMPs for production activities in the manufacturing facilities. Review company and site-specific SOPs, policies, and procedures and develop processes that meet the quality requirements set forth in these documents. Qualifications Must-Have * A minimum of a BS degree + 10 years of experience; MS + 7 years of experience; PhD + 4 years of experience in any of the following disciplines: Chemistry, Biochemistry, Biotechnology, Chemical Engineering, Chemistry, or equivalent science related or engineering discipline. * Knowledge of the manufacturing process and equipment, preferably filling and visual inspection processes. Experience in automation including PLC/DeltaV and equipment validation is desired. Direct knowledge and experience inmanufacturing execution and tech transfer within a Biopharmaceutical/pharmaceutical cGMP environment. PHYSICAL/MENTAL REQUIREMENTS Some standing, ladder climbing, bending, pushing and lifting (up to 40 lbs.) may be required on a daily basis when the colleague is supporting work in manufacturing. Other job functions require working in an office setting where sitting and computer usage would be the norm. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Schedule is primarily day shift, but at times it will be necessary to work according to the manufacturing shift schedules (1st, 2nd or 3rd shift) to support execution of batch records when manufacturing batches during a tech transfer. Relocation support available Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Manufacturing #LI-PFE Pfizer Sanford FL

Manufacturing Process Engineer (3Rd Shift)

Pfizer