Validation Engineer

Proclinical is currently advising on behalf of one of the world's most prestigious pharmaceutical companies, who are currently seeking a Validation Engineer to join their South Carolina offices. The Validation Engineer performs installation and operation verification and performance testing of new or modified process and lab equipment implemented through the change control system. This is a contracted role.

Job Responsibilities:

• Developing project execution plans and managing small to medium sized projects.
• Authoring commissioning, qualification and validation plans.
• Authoring and executing validation protocols and summary reports, along with requirement trace matrices.
• Liaising with client end user groups to ensure correct specification of equipment and utilities.
• Validating via risk-based approaches, such as FMEA and PHA.
• Performing risk assessments to confirm sale/compliant designs and recommending additional controls as required.
• Reviewing project documentation, such as URS, FRS, Technical Specifications and Functional Specifications.
• Reviewing process models and sizing calculations for process equipment, control valves, etc.
• Participating in discussions with internal business partners on priorities, timeliness, and transparent sharing of information.
• Partnering with Quality to ensure a quality and compliant manufacturing environment.

Skills and Requirements:

• A minimum of a B.S. degree in Engineering, Science or related technical field.
• A minimum of 5 years of experience in biotech or pharmaceutical based GMP manufacturing operations. This includes experience in cell culture, recovery, purification, aseptic fill/finish.
• A minimum of 3 years of experience in the design or operation of commercial grade pharmaceutical or bio-tech process equipment and utilities.
• An ability to read/interpret engineering drawings and design documents.
• Excellent technical writing and verbal communication skills.
• Must be people oriented and a team player.
• Proficiency in Microsoft Word, Excel, PowerPoint, Project and Visio.
• An in-depth knowledge of FDA regulations, particularly 21 CFR part 11, 210, 211.
• Working knowledge of ICH Q8, Q9, Q10 and other international regulatory requirements.
• Familiarity with the following equipment: pumps, fermenters, centrifuges, UF/DF systems, TFF systems, chromatography columns, fillers.
• Experience managing 3^rd parties (both in-sourcing and outsourcing).
• An ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Approximately 10% travel required.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Joseph Emmott on +44 203 814 1316 or upload your CV on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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