Our biotech client require a Validation Engineering contractor for an initial 12 month period. Superb remuneration available. Easy to convert to becoming a contractor for current permanent staff, also.
Development of Validation Plans, Cycle Development, Performance Qualifications, Requalification Protocols and System Summary reports for Autoclaves, Steam in Place Systems and Controlled Temperature Chambers (CTCs).
Prepare, execute, document and report validation protocols in line with GMP’s and other regulatory requirements and standards.
Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
Review and Approve validation protocols and assessments from a quality system documentation perspective.
Assist in deviation, exception resolution and root cause analysis.
Participate as required in project activities.
Autoclave load qualification, Depyrogenation tunnel qualification and SIP qualification (including Lyophilisers & vessels) in support of a new product introductions. In addition the qualification of CTC’s across the site to support ongoing projects.
Bachelor of Science/Engineering degree or equivalent.
Knowledge of cGMP’s and other worldwide regulatory requirements.
Problem solving ability and excellent oral and written communications skills
Knowledge of the use of Biological indicators and Thermal Mapping to demonstrate system sterility/temperature control
Hands-on experience with temperature mapping equipment, eg Ellab, LIVEs or equivalent
Bio tech/Pharma background circa 5 years min
Contact Brian Christensen on 01 6854747 or submit your CV to email@example.com for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747