Validation Specialist

Hobson Prior are seeking a Validation Specialist to join a growing biotech on a permanent basis in Stevenage. This role is accountable for authoring, executing and reporting validation activities within the framework of cGMP - Annex 11 & 15 and in compliance with the organisations QMS requirements.

Job Responsibilities:

• You will support validation activities including input into defining the validation requirements to ensure compliance with Annex 11, 15 and industrial guidance such as GAMP.
• Uphold up-to-date knowledge of validation standards and regulatory compliance requirements.
• Work with validation contractors to support commissioning and start-up activities, support validation contractors as needed for validation activities once collaborator production has started to maintain the validated state.
• Supervise validation testing performed by vendors to ensure work is complete and accurate, work with vendors for issue resolution and validation deviation reporting.
• Assist in the authoring of User Requirement Specifications, Design / Installation / Operational / Performance Qualification protocols and reports for validation purposes.
• Undertake validation project execution DQ/IQ/OQ/PQ in conjunction with relevant stakeholders ensuring timelines are met and deliverables achieved.
• Be involved in the implementation of a risk-based approach to the validation of systems in accordance with EU GMP Annex 11, 15, US FDA and GAMP guidelines, along with company quality documents and guidelines.
• Attend and participate in design meetings, and factory acceptance tests at vendor sites.
• Author and report validation documentation to meet regulatory and company standards.
• Recognise, develop and maintain stakeholder relationships.
• Support and adhere to company policies and procedures.

Key Skills:

• Highly motivated and pragmatic.
• Able to evaluate complex situations and find solutions for them in a professional manner.
• Project ownership and pride in its delivery.
• Having a passion for delivering excellent customer service in a cost-effective way.
• Flexibility towards work assignments and new learning.
• Excellent oral and written communication skills.

Requirements:

• Qualifications related to validation and quality compliance (cGMP/ICH/FDA/USP/EP policies/guidelines).
• Member of a recognised professional body is admirable.
• Demonstrable validation experience in Biopharmaceutical products, or combination of Validation and Engineering/Commissioning experience.
• Experience of collaborating successfully with validation teams, and a network of external contracted resources.
• Experience of successful interfacing with Facilities, Quality, Operations and Information Technology groups to develop requirements, establish programs and manage day-to-day operation.
• Understanding of utility systems, process instrumentation, automation systems, and analytical equipment.
• Experience of establishing function-appropriate qualification programs for laboratories (development and Quality Control).

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.