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.