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.
