We are seeking highly skilled technical professionals capable of providing commissioning and qualification services within the Pharmaceuticals, Biotechnology, and Medical Devices Manufacturing industries.
The Computer System Validation (CSV) Specialist/Engineer will play a crucial role in the development and execution of software and equipment qualification processes.
Responsibilities:
- 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.
Qualifications:
- Bachelor of Science in Engineering or equivalent
- Experience in the Bio/Pharmaceutical industry.
- 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.
Job Type:
- Full-time
Education:
- Bachelor’s (Required)
Experience:
- Computer Systems Validation (CSV): 5 years (Required)
Language:
- Spanish (Required)
- English (Required)
Ability to Commute:
- Juncos, PR 00777 (Required)
Ability to Relocate:
- Juncos, PR 00777: Relocate before starting work (Required)
Work Location:
- In person