Overview
PE Global is recruiting a manufacturing engineer for our pharmaceutical client based in Speke, United Kingdom. The role is an initial 12-month contract.
Responsibilities
- Provide packaging process and material expertise
- Participate in Joint process team (JPT) meetings as primary TSMS; ensure technical requirements of global standards are met.
- Change management.
- Maintain oversight of key batch processing records used at CMs, including SOP’s, Master Production Records, SPI’s.
- Support writing and write technical reports to convey status of key initiatives, and to communicate process metrics.
- Participate in site visits to the CM, to assess ongoing capability and, as required, to support resolution of complex technical issues and/or support implementation of significant process or procedural changes.
- Ensure that assigned products have an appropriate control strategy.
- Use data and process knowledge to identify continuous improvement (CI) opportunities.
- Support generation and review Annual Product Reports (APRs) / PQR’s.
- Support writing of potential technical inquiry Position Papers for support of submissions, internal inspections or Health Authorities related to key products in scope.
- Manage product / process transfer projects from a TSMS perspective
- Working closely with the TS/MS Leads and Operations, support investigations related to deviation & complaints.
- Support new product introductions and technical transfer of existing processes within and between internal / third parties.
Qualifications
- An advanced university degree or demonstrated career experience in life science or engineering (e.g. pharmacy, chemistry, chemical engineering, veterinary medicine, packaging engineering).
- Fluent in English and another European language.
- Requires a minimum of 5 years' experience in pharmaceutical or chemical production, technical services, and/or packaging (processes, materials, and design) within a technical production function.
- Thorough understanding of production processes.
- Strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities.
- Strong Project management skills, strong communication skills, experience in working with interdisciplinary, multicultural teams as well as with external partners.
- Experienced in technical transfer or project management of production processes at manufacturing scale.
- Multi-tasking and priority management essential.
- Confident in team environment to contribute and challenge the status quo and take a technical stand when required - can represent technical information to senior management in a clear and concise manner.
- Expert in reviewing and writing technical reports. Can author technical documents to a high standard and is current with cGMP requirements in aspects of process validation, process change design and process monitoring compliance.
- Can apply excellent problem-solving methodology to complex technical situations within required deadlines using statistical data analysis as a tool and means to identify improvements.
- Flexibility in travel (sometimes at short notice) to support business deadlines and customer requirements.
Note: PE Global cannot assist with visa sponsorship. Candidates must have a valid right to live and work full time within the UK for at least the next 12 months.
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