About this role
About the Role The CSV Specialist/Engineer will lead the development and execution of software and equipment qualification processes within the Pharmaceuticals, Biotechnology, and Medical Devices Manufacturing industries, ensuring compliant validation of systems and equipment. What You'll Do
- Generate and execute validation documents, including protocol creation and testing within the bio-pharmaceutical industry.
- Create and seek approval for validation documents such as C&Q Plan, URS, Design Specs, Requirements Traceability Matrix, and Summary Reports tailored for the Biopharmaceutical industry.
- Revise Design Specifications as necessary to align with new design requirements.
- Develop qualification protocols for new or modified manufacturing equipment, utilities, and facilities.
- Prepare comprehensive summary reports based on the results of validation and qualification tests, as well as reviews of procedures and protocols.
- Provide support during implementation, collaborating with affected departments and personnel.
- Actively participate in progress meetings to ensure affected departments are kept up to date with project achievements and communicate any action items necessary to maintain project schedules. What We're Looking For
- Bachelor of Science in Engineering or equivalent
- 5 years experience in Computer Systems Validation (CSV)
- Proficient in Commissioning & Qualification documentation
- Familiarity with CSV regulations and guidelines, including cGMP, ISPE GAMP process, 21 CFR Part 11, 21 CFR 211.68, and Data Integrity
- Strong analytical thinking and problem-solving skills
- Team-oriented, capable of collaborating with technical experts, design teams, and other departments
- Quality and results-oriented mindset
- Computer literate with excellent verbal and written communication skills in both English and Spanish
- Exceptional attention to detail, with the ability to independently proof work for accuracy
- Language: Spanish (Required); English (Required)
- Ability to Commute: Juncos, PR 00777 (Required); Relocate before starting work (Required)
- Work Location: In person