Manufacturing Engineer

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.

Please 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.