Production Scientist

PE Global is currently recruiting for a Manufacturing Specialist for a 12 month contract role with a leading multinational Animal Health client based in Speke.

We are looking for an experienced person having had exposure to pharmaceutical production and having touched different technologies (powders, liquids, sterile products, ointments creams, tablets, vaccines).

Besides the ideal incumbent had exposure to packaging design (meaning having experience in materials, product interactions, knowledge of GMP requirements on packaging materials and data to be generated for filing purposes, transport studies, molding of bottles and tubes, container closure integrity testing).

Job 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.
• 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.
• Act as primary TSMS contact for assigned contract manufacturers an participate in the Joint process teams (JPT).

Requirements

• An advanced university degree or demonstrated career experience in life science or engineering.
• 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.
• 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.

Interested candidates should submit an updated CV.

Please click the link below to apply.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***