Validation Engineer – Contract Role
Overview:
We are seeking a Validation Engineer to support ongoing product introductions, equipment qualifications, and the site requalification program at a GMP-regulated manufacturing facility.
Key Responsibilities:
* Design, execute, and report on process validation (PV) and process performance qualifications (PPQ).
* Perform validation studies for equipment, systems, and processes.
* Ensure compliance with cGMP, health & safety, and regulatory requirements.
* Provide technical guidance on FDA/EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Maintain validation documentation throughout the lifecycle.
* Participate in inspections and support change control processes.
Requirements:
Experience & Skills:
* 3–5 years in healthcare/pharma manufacturing, ideally with exposure to product validation and equipment qualification.
* Strong understanding of GMP, process validation, and regulatory guidelines.
* Experience with GAMP, ISPE guides, and standards such as AAMI/ANSI, PDA, and ISO.
* Capable of troubleshooting and supporting validation-related investigations.
* Familiarity with quality management systems and validation tools (e.g., MS Project, SPC, Kneat is a plus).
Soft Skills:
* Proactive, team-oriented, and solutions-driven.
* Strong communication and organizational abilities.
* Able to manage workload and deliver to deadlines.
Education:
Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical, Mechanical, Electrical).
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