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Seeking a Validation Engineer to support a new project, focused on ensuring ongoing compliance and validation of equipment, systems, and processes in a GMP-regulated manufacturing environment.
Key Responsibilities:
* Prepare and execute FAT/SAT/IOQ protocols, including report generation.
* Plan, conduct, and document validation studies for equipment, systems, and processes.
* Ensure compliance with cGMP, HSE, and regulatory standards.
* Provide guidance on validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation.
* Maintain validation documentation throughout its lifecycle.
* Support change control activities and participate in inspections.
Requirements:
Experience & Skills:
* 3–5 years in a regulated healthcare or pharmaceutical manufacturing environment.
* Strong knowledge of process validation, GMP, and technical transfer practices.
* Familiar with GAMP, ISPE guidelines, and relevant FDA/EU regulations.
* Experience with equipment such as autoclaves, isolators, fill lines, and packaging systems is advantageous.
* Proficient in troubleshooting and root cause analysis.
* Experience with validation software (e.g., Kneat) and knowledge of MS Project/SPC tools is a plus.
Education:
* Degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical, Mechanical,
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Industries
Pharmaceutical Manufacturing
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