Department: VEG
Location: Humacao, 069
Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Engineer - Upstream
Description:
We are seeking a Validation Engineer with experience in upstream equipment to join our team. The Validation Engineer will be responsible for validating equipment, processes, and systems used in the manufacturing process to ensure compliance with industry standards and regulations. Knowledge of common upstream equipment in biotech is a plus.
Qualifications:
- Bachelor's degree in Engineering or related field.
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Proven experience as a Validation Engineer in a manufacturing environment.
- Strong knowledge of upstream equipment and processes, including but not limited to: fermenters, bioreactors, centrifuges, filtration systems, and chromatography equipment.
- Familiarity with industry regulations and standards.
- Excellent problem-solving skills and attention to detail.
- Effective communication skills and ability to work in a team environment.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
- Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
- Develop and execute validation protocols for equipment and processes.
- Coordinate with cross-functional teams to ensure validation requirements are met.
- Analyze validation test results and prepare reports documenting findings.
- Identify and address deviations or non-conformances during the validation process.
- Support continuous improvement initiatives related to equipment validation.
At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.
