Validation Specialist
We are seeking an experienced Validation Specialist to support validation activities within a state-of-the-art aseptic manufacturing facility. This role will focus on ensuring GMP compliance across critical manufacturing systems, equipment, facilities, and processes involved in sterile drug product manufacturing.
The successful candidate will work closely with Manufacturing, Quality, Engineering, and CQV teams to execute and maintain validation programs supporting ongoing commercial operations and project activities.
Key Responsibilities
- Author, execute, and review IQ/OQ/PQ protocols for manufacturing equipment, utilities, and facilities.
- Support qualification of aseptic processing equipment including filling lines, isolators, RABS, autoclaves, depyrogenation tunnels, and lyophilizers.
- Perform validation activities for critical utilities including WFI, Clean Steam, Compressed Gases, and HVAC systems.
- Execute process validation and cleaning validation activities within GMP manufacturing environments.
- Review and assess validation documentation to ensure compliance with regulatory requirements.
- Support investigations, deviations, CAPAs, and change controls related to validation activities.
- Collaborate with Quality Assurance and Manufacturing teams during audits and regulatory inspections.
- Ensure validation lifecycle activities are maintained in accordance with FDA, EMA, and cGMP requirements.
Requirements
- Bachelor's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
- Experience within aseptic pharmaceutical or biotechnology manufacturing environments.
- Strong knowledge of equipment qualification, process validation, cleaning validation, and utility qualification.
- Experience authoring and executing validation protocols and reports.
- Familiarity with GMP regulations, Annex 1, FDA, and EMA requirements.
- Experience supporting sterile manufacturing processes is highly desirable.
- Strong communication and stakeholder management skills.
Preferred Experience
- Aseptic filling operations.
- Sterile manufacturing validation.
- Environmental monitoring programs.
- CQV project support.
- Investigation and deviation management.
- Regulatory inspection readiness activities.
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