Senior Process Validation Engineer
We are seeking an experienced consultant for the validation of fill & finish processes for one of our client. The ideal candidate will have a strong background in the pharmaceutical industry and will ensure that production processes comply with regulatory standards and Good Manufacturing Practices (GMP).
Responsibilities:
- Plan and execute validation activities for fill and finish processes.
- Draft and review validation protocols and associated reports.
- Ensure production processes comply with regulatory standards (FDA, EMA, etc.).
- Collaborate with production, quality, and engineering teams to optimize processes.
- Identify and resolve issues related to process validation.
- Train and mentor teams on validation procedures.
Key Competencies:
- Expertise in fill and finish process validation.
- In-depth knowledge of regulatory standards and GMP.
- Ability to draft clear and precise validation protocols and reports.
- Project management and problem-solving skills.
- Excellent communication and collaboration skills.
- Ability to work independently and as part of a team.
- Proficiency with computer tools and validation software.
Desired Profile:
- Degree in pharmaceutical sciences, engineering, or a related field.
- Minimum 10 years of experience in the pharmaceutical sector, specializing in process validation.
- Proven experience in fill and finish process validation.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Analytical mindset and attention to detail.
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