Description

Pay Rate: XXX

Quality Assurance, Manufacturing Process Validation Engineer III

When you join us at Client Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of XXX billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The role is responsible for Manufacturing Process Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.

How will you make an impact?

The Manufacturing Process Validation Engineer will be responsible for defining, implementing and maintaining a robust process validation program. This will include ensuring the validation program complies with regulatory agency expectations and developing and executing validation documentation including protocols, final reports, deviations and SOPs while ensuring compliance to GMP requirements.

What will you do?

• Develop and execute process validations; perform risk assessment and gap analysis for process validations.
• Optimize the process validation policies, procedures and systems to increase efficiency and compliance with regulatory agencies.
• Perform periodic process review, risk assessments, and re-validation to ensure continued compliance. Define and ensure timely completion of validation deliverables for projects to meet scheduled timelines.
• Author studies, plans, protocols, and reports for manufacturing validation processes.
• Lead investigations for deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings.
• Develops and authors change controls for validation changes.
• Coordinate and provide training and/or opportunities for career development of others.
• Perform other duties as assigned.
• Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.

How will you get here?

Education

• Bachelor s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

• Minimum of 3-5 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of two (2) years direct process validation experience.
• Solid understanding of GMP guidance, including 21 CFR Part 11, and Annex 11.
• Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
• Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.

Knowledge, Skills, Abilities (Required)

• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems in Biotech and/or Pharmaceutical industry
• Excellent communication and listening skills
• Ability to build and maintain strong collaborative relationships across multiple departments
• Microsoft Office and database management skills
• Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.

Knowledge, Skills, Abilities (Preferred)

• Experience with biological manufacturing processes.
• Project Management advanced experience.
• Certified Lean Professional or Six Sigma