Responsibilities:
- Develop and execute Commissioning, Qualification, and Validation (CQV) protocols (IQ/OQ/PQ) for pharmaceutical manufacturing facilities, equipment, and systems.
- Collaborate with project teams to ensure compliance with regulatory standards (e.g., FDA, EMA, GMP).
- Perform risk assessments, gap analysis, and prepare validation documentation.
- Support the design and implementation of validation strategies for process and utility systems (e.g., HVAC, water systems, cleanrooms).
- Lead or participate in FAT, SAT, and related commissioning activities.
- Ensure all CQV activities meet project timelines and budget requirements.
- Provide technical expertise during audits and regulatory inspections.
- Continuously monitor and improve validation processes in alignment with industry standards and innovations.
Requirements:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 3-5 years of CQV experience in the pharmaceutical or biotechnology industry.
- Strong knowledge of GMP, FDA, and other regulatory requirements.
- Hands-on experience with CQV of manufacturing equipment, including bioreactors, lyophilizers, or packaging lines.
- Familiarity with computerized systems validation (CSV) is a plus.
- Excellent analytical, communication, and project management skills.
- Ability to work effectively in cross-functional teams.
Preferred Skills:
- Experience with qualification and validation of single-use systems.
- Familiarity with automation systems such as DeltaV or other DCS platforms.
