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Master CQV Professional
2 weeks ago
Senior Validation Specialist Position
Description:
The ideal candidate will have a proven track record in commissioning, qualification, and validation (CQV) activities for manufacturing equipment, utilities, and computerized systems.
Key responsibilities include developing and reviewing documentation such as user requirements specifications (URS), design qualification (DQ), functional performance qualification (FAT), site acceptance testing (SAT), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and risk assessments.
Additional duties include managing validation master plans and system impact assessments, collaborating with cross-functional teams to ensure seamless integration into capital projects, conducting remote support and data review, and validating strategies.
The successful candidate must possess a bachelor's or master's degree in engineering, life sciences, or a related field, along with 10+ years of hands-on CQV experience in the pharmaceutical and/or medical device industries.
Strong understanding of regulatory requirements including FDA, EU Annex 15, ICH Q8-10, and ISO 13485 is essential, as well as expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
Proficiency in using validation lifecycle software and document management systems is also required. Experience working in remote project environments and knowledge of Agile, Lean Six Sigma, or project management certifications are highly valued.
Required Skills:
- Proven experience in CQV activities
- Excellent communication and collaboration skills
- Deep understanding of regulatory requirements
- Expertise in GAMP 5 and 21 CFR Part 11
- Proficiency in using validation lifecycle software
Benefits:
This role offers the opportunity to work on challenging projects, collaborate with a talented team, and develop your career in a dynamic and growing industry.
Preferred Qualifications:
- Experience with sterile manufacturing, biologics, cell/gene therapy, or combination products
- CQV experience in greenfield or brownfield capital projects
- Knowledge of Agile, Lean Six Sigma, or project management certifications
