Validation Specialist

Evonik Birmingham , AL 35202

Posted 2 months ago

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VACANCY REFERENCE NUMBER 130781

Validation Specialist

Location: United States : Birmingham, AL

Function: Production & Technology

Career Level: Experienced professionals (2-5 years)

Legal Entity: Evonik Corporation

Business Line: Health Care

What we offer

You will work on exciting and challenging topics together with a team in an ultra-modern, innovative and creative environment. Intensive on-the-job training with expert colleagues guarantees you will quickly become familiar with your duties and perform them independently. Performance related pay and the opportunity for personal and professional development are of course part of the package. Since 2009 Evonik Industries AG has been certified as a family-friendly company by the German Hertie Foundation.

Click here to learn more about Evonik from our employees

The Validation Department ensures equipment/systems meet engineering specifications, company quality standards, and regulatory expectations. Validation is an integral part of design, procurement, installation, startup, proof of compliance to regulatory agencies (FDA and EU) and ongoing monitoring for regulatory compliance. It is an industry expectation that validations is part of the pharmaceutical manufacturing process from early research and development through commercial manufacturing and decommissioning of systems.

Validation Specialists support the Validation Department by providing Subject Matter Expertise (SME) in a discipline(s) owned by the validation department. These disciplines are; Commissioning and Qualification, Sterility Assurance, Cleaning Validation, Computer Systems Validation, Method Validation, Process Validation, Validation Maintenance/Risk Management, and Application of Statistical Technique. The Validation Specialist can own creation, periodic review and compliance of Validation Plans and Procedures. Validation Specialist(s) support project teams, which require a validation resource and are capable to lead such teams. This position can support client and auditor interactions.

Validation Specialist(s) are individual contributors within the validation group. This position can perform at a high level within the Validation Department but is also able and willing to function at any level as needed. Also, the Validation Specialist is primarily responsible for their growth and development within the department. The Validation Specialist performs with a high degree of autonomy and is able perform on interdisciplinary teams. This position leads by example, achieves solutions to complex problems, serves as a technical expert, communicates effectively and bridges GAPs.

Validation Specialist is able to support the unique needs of a 24 hour production facility. This position is a 1st shift position but will be able to support off shift and weekend efforts as they occasionally arise.

RESPONSIBILITIES

  • Create/Own Validation Plans, Procedures and Projects

  • Manage assigned projects, ensuring activities are on time and within budget, meet cGMP requirements

  • Demonstrate quality practices, ensure projects are compliant with inspection agencies' (FDA, EU) requirements and Evonik practices

  • Develop Validation strategies

  • Drafts technical documents such as white papers

  • Owns Deviations, CAPA's, Change Controls and other deliverables to the Quality System

  • Provide support in training, developing department staff

  • Provide support to external departments for tasks that require a validation resource

  • Reviews Plans, SOP's and Packages ensuring ongoing compliance with Evonik Standards, Policies and Procedures

  • Reviews and approves Validation Packages ensuring the results/conclusions are accurate and are in compliance with Site Plans and Procedures

  • Supports Engineering, Innovation Management, Quality, Operational

  • Compliance and Manufacturing by reviewing and approving engineering and technical documents (URS, Drawings, Cut Sheets, Design Specifications, Certifications, EAF, ETOP, Manuals, Technical Reports, Engineering Studies, Risk Assessments, CAPA, Deviation, Change Control, and SOPs)

  • Design, conduct, and evaluate results from experiments, studies, and research programs in order to meet project goals and objectives; project activities may range from process development and scale up, equipment specification, document support, validation protocols and execution and cGMP manufacturing operations

  • Identify Continuous Improvement (CI) opportunities related to Facility equipment, materials management, yield and procedures. Take action independently to implement improvements. Maintain training on Evonik Quality and Compliance systems

  • Support client and auditor interactions

  • Perform review and approval within the quality systems for the Validation Department

  • Establishes safety as the number one priority through training, actions and behaviors

  • Adhere to all company safety, health and environmental policies, procedures and directives

  • Conduct all experiments in a safe manner by use of MSDS to establish chemical hazards; observe the appropriate laboratory procedures; and report all incidents that could threaten the safety of laboratory personnel

REQUIREMENTS

  • Bachelor's degree preferably in Science or Engineering discipline. Other disciplines and/or equivalent job experience will be considered.

  • Five (5) or more years preferred in a aseptic pharmaceutical manufacturing role with SME status preferably in Cleaning Validation

  • Strong problem-solving and critical thinking skills with demonstrated ability to conduct technical programs and to achieve program goals; strong organization skills to handle and delegate multiple projects at differing levels of complexity

  • Excellent interpersonal skills

  • Effective written and verbal communication skills; ability to clearly and effectively communicate observations and outcomes to all levels of employee within the company

  • Comprehensive knowledge of pharmaceutical manufacturing equipment and processes

  • Ability to work closely and effectively with other workgroups in order to successfully complete projects on time and thoroughly

  • Knowledge of the use of personal protective equipment and safety practices related to working with or exposure to hazardous materials that may potentially affect the health of the employee

  • Ability to

  • Work independently or within a team environment;

  • Perform work utilizing a computer for extended periods of time;

  • Sit for extended periods of time without being able to leave the work area;

  • Stand for extended periods of time without being able to leave the work area;

  • Grasp objects utilizing the fingers (fine motor manipulation);

  • Reach for objects above the head or below the waist;

  • Stoop or crouch by bending at the waist or by bending the legs;

  • Determine colors

  • Lift 50 lbs

  • Qualify for Aseptic Gowning

  • Qualify for Visual Inspection

  • Proficient in the use of word processing, spreadsheet and presentation software programs. Statistical software proficiency, a bonus

  • A thorough understanding and application of relevant scientific theories, principles, and methods.

  • Capable of performing and applying standard scientific tests, procedures and techniques

  • Experience with a variety of formulation, processing, analytical, and manufacturing equipment and instruments

  • Ability to train personnel and supervise technical activities

Your Application

To ensure the fastest process of your application and to protect the environment, please apply online via our careers portal at https://careers.evonik.com.

VACANCY REFERENCE NUMBER 130781

Evonik Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, gender, sexual orientation, national origin, disability status, protected veteran status or any other legally protected status.

Please note that Evonik will not accept any unsolicited application documents sent by staffing firms. Evonik works in conjunction with preferred service providers and will not pay any fee to staffing firms in the absence of an appropriate framework agreement. Should Evonik receive a candidate profile from a staffing firm with which it has no framework agreement, and should this candidate subsequently be considered in the recruitment process or offered employment, no claims from the staffing firm will be entertained in this regard.

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Validation Specialist

Evonik