Validation Engineer

Pinnaql; Barceloneta (PR); On-site; USD 85,000 - 110,000; Full time

Job summary

Validation & Engineering Group, Inc. (V&EG), a Pinnaql company, seeks a Validation Engineer with hands-on experience in aseptic filling operations to support equipment, processes, and computerized systems in regulated environments.

Responsibilities include developing validation master plans, SOPs, and reports, while ensuring 21 CFR Part 11 data integrity and cross-functional collaboration with Manufacturing, QA and Engineering teams.

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, or related field.
• 3–7+ years of validation experience in biotech or pharmaceutical industry.
• Experience with aseptic processing and vial filling.
• Proficient in English and Spanish.
• Familiar with cGxP and regulatory guidance.
• Experience with IQ, OQ, PQ protocols and validation reports.

Responsibilities

• Develop, review, and execute IQ/OQ/PQ for aseptic lines (vial filling, stopper, cap).
• Validate equipment like autoclaves and depyrogenation tunnels.
• Perform process validation including media fills.
• Ensure compliance with cGMP, FDA, EMA, ICH guidelines.

Skills

Aseptic processing

Vial filling operations

Sterile manufacturing environments

MS Windows / MS Office

Education

Bachelor's degree in Engineering, Chemistry, Biology, or related field

Job description

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

Description

We are seeking a Validation Engineer with hands-on experience in biotech/pharmaceutical manufacturing, specifically supporting aseptic filling operations (vials). This role will be responsible for executing and supporting validation activities for equipment, processes, and computerized systems in compliance with regulatory requirements and industry standards.

Responsibilities

• Develop, review, and execute validation protocols including IQ, OQ, PQ for:
  • Aseptic filling lines (vial filling, stoppering, capping)
  • Lyophilization (if applicable)
  • Support equipment (autoclaves, washers, depyrogenation tunnels)
• Perform process validation activities related to sterile manufacturing, including media fills (APS).
• Ensure compliance with cGMP, FDA, EMA, and ICH guidelines.
• Support commissioning and qualification (C&Q) activities for new equipment and facility upgrades.
• Generate and review:
  • Validation master plans (VMPs)
  • SOPs, protocols, and final reports
• Collaborate with cross-functional teams (Manufacturing, QA, Engineering, MSAT).
• Investigate deviations, CAPAs, and implement corrective actions related to validation activities.
• Support risk assessments (FMEA, impact assessments) for validation scope.
• Ensure data integrity and adherence to 21 CFR Part 11 requirements (if applicable to systems).

Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, or related field.
• 3–7+ years of validation experience in biotech or pharmaceutical industry.
• Strong experience with:
  • Aseptic processing
  • Vial filling operations
  • Sterile manufacturing environments
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• 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.

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.