Validation Engineer

Summary

To ensure manufacturing processes, packing operations, equipment, cleaning methodologies, utilities/facilities, computer and analytical methods and associated services are fully validated to meet expected operational excellence requirements and GMP / regulatory requirements of all countries.

Job Purpose

• Prepare, execute and report validation protocols and SOPs with responsibility across equipment / production / facilities & utilities / Analytical Methods /computer systems / cleaning studies in GMP environment.

• Follow Biotech/Pharmaceutical/Medical Device industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications, and requirement specifications.

• Implement validation strategy based on current regulatory and pharmaceutical industry standard and quality expectations.

• Ensure validation is delivered on time to support product introductions/launches and any regulatory requirements are met either as a result of licence activity or site audit.

• Maintenance of validation system ensuring all processes, equipment and validation services remain current to GMP standards.

• Ensure validation gaps and risks are identified and addressed, to support ongoing release, licence submission/renewal, and ensure an audit ready situation.

• Planning and managing validation of CAPEX projects and strategic systems using risk based approaches (identification of CCPs, FMEA, ICH Q9).

• Working in a multicultural and multidisciplinary environment (production, QA, laboratories, suppliers, engineering and technical teams).

Main Challenges

• Co-ordination of validation activities with key support functions.

• Maintenance of validation master plan to agreed timelines.

• Ensure validation is conducted on fully developed processes.

• Ensure that validation requirements allow launch/routine product delivery times.

• Validation reporting delivered to meet launch commitments.

• Capturing all operational requirements to ensure processes meet GMP and operational effectiveness requirements.

Requirements

• Life Science / Engineering degree.

• 2 to 3 years pharmaceutical experience or associated manufacturing industry experience.

• In-depth knowledge and experience of manufacturing technology applied on manufacturing site.

• Knowledge in sterile, solid and liquid dosage forms.

• Experience in Validating processes, equipment, cleaning methodologies, utilities/facilities, computer and analytical methods.

• Broad knowledge of pharmaceutical manufacturing processes.

• Good inter-personal skills and presentation skills. Can influence at all levels.

• Primary Location: UK.

Desired Knowledge

• FDA 21 CFR part 11• Eudralex Volume 4• ICH Q7

Behaviours

Professional, hands on, self motivated, able to work on own initiative.

Confident, able to deal with people at all levels.

Completer/finisher with a can-do attitude.

Able to effectively prioritise, work under pressure and maintain deadlines.

Good communicator with the ability to communicate complex information to non-technical colleagues.

Good problem solving skills.

Please correspond with CV and covering letter and salary expectations.

For more information on this role , please email:

info@bcijobs.com