The Facilities Validation department supports the manufacture and development of PBL products. It is responsible for ensuring compliance to the cGMP guidelines on Validation for all systems involved in the manufacture, storage and testing of PBL products.
The purpose of this role is to take the lead to execute validation activities relating to Temperature controlled units, Utilities and Sterilisation systems. This will involve coordination with Engineering, Production, QC and QA departments to ensure a timely delivery of the qualification report. The post holder may be expected to supervise contractor resource where appropriate with responsibility to ensure adequate training and supervision is provided.
The post holder will be required to write, review and where appropriate approve validation reports prior to execution, followed by report generation. The scope of the work will involve (but not limited to) the qualification of Fridges, Freezers, Incubators, Autoclaves, Hot air ovens, HVAC systems, Clean rooms, Compressed gasses, Wfi, Purified Water and Clean steam systems.
In addition to Utilities and Sterilisation validation activities the post holder will be expected to undertake any related validation activities deemed necessary by line management. This could include the generation of validation documentation in accordance with the full validation life cycle for equipment, utilities and facilities.
MAIN DUTIES AND RESPONSIBILITIES
- Manage, execute and deliver equipment Validation projects according to the business priorities and project time-lines. ?
- Writing, reviewing and approving validation protocols. ?
- Be able to work alone or within a matrix team structure. ?
- Follow up and resolve discrepancies, CAPAs and non-conformances In lines with overall responsibilities, perform additional tasks assigned by the Line - manager.
- Undertake all work in accordance with local safety and security procedures.?
- Educated to BTEC National Certificate level in biology sciences discipline or significant related experience.
KNOWLEDGE AND EXPERIENCE
- Previous experience of working in a GMP pharmaceutical environment.
- Experience with coordinating activities.
- Understanding of the significance of validation in a cGMP environment.
SKILLS AND CAPABILITIES
- Problem solving skills.
- An ability to maintain confidentiality and trust.
- Clear communicator with good written and verbal, and data entry skills.
- Established use of Microsoft Office.
- Experience of dealing with internal customers, identifying and taking the lead in delivering work programmes.
PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / ANALYTICAL / EQUIPMENT / PHARMACEUTICAL PRODUCTION / MAINTENANCE / CONSUMABLES / QUALITY CONTROL / ENVIRONMENTAL / GMP / SUPERVISOR / TECHNICAL FILES / TECHNICAL DOCUMENTATION / FPP / CLEANING / cGMPs / METHODS / SAMPLES / TECHNIQUES / SYSTEMS / CONSUMABLES / IDENTIFYING / EVALUATING / MATERIALS / TECHNOLOGIES / PBL / ADAPTING / POLICIES / PROCEDURES / MANUFACTURING / VALIDATION / STERILISATION / CONTROLLED UNITS / REPORTS /