- Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.
- Perform risk assessments and impact analysis related to system validation.
- Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.
- Manage change control and deviation investigations related to validated systems.
- Support audits and inspections by regulatory authorities.
- Maintain validation documentation and ensure traceability throughout the system lifecycle.
Requirements
- Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.
- 5-8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.
- Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.
- Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.
- Excellent documentation and communication skills.
- Ability to work independently and in cross-functional teams.
Skills Required
- Bachelor's degree in Pharmacy, Life Sciences, Engineering, Computer Science, or a related field
- 5-8 years of experience in computerized system validation within pharmaceutical manufacturing or related regulated industries
- Strong knowledge of GxP regulations, FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines
- Experience validating PLC, SCADA, MES, or other pharmaceutical manufacturing automation systems
- Excellent documentation and communication skills
- Ability to work independently and in cross-functional teams
What We Do
Founded in 1996, PSC Biotech Corporation was created with the vision of providing life science companies unmatched support. To date, PSC Biotech Corporation now serves 1000 clients in more than 35 countries worldwide through professional services consulting, cloud-based software solutions, pharmaceuticals contract manufacturing, life science investment consulting, and metrology services. PSC Biotech Corporation has six unique divisions within the parent company – each representing one of our areas of expertise: PSC Biotech, PSC Software, BioTechnique™, PSC Partners, PSC Metrology and PSC Investments. Additionally, PSC Asia and PSC Biotech Ltd represent PSC Biotech Corporation in Asia and Europe, respectively. Together, these divisions enable us to meet the ever-changing needs of our clients with a commitment to excellence and superior quality.
