Manufacturing Engineer

PE Global; Liverpool; On-site; GBP 40,000 - 55,000; Full time

Job summary

A pharmaceutical services provider is seeking a manufacturing engineer for a 12-month contract in Liverpool. The role involves providing expertise in packaging processes, participating in joint process teams, and supporting technical transfer projects. Candidates should possess an advanced degree and at least five years of experience in pharmaceutical production. Strong communication and project management skills are essential. This position does not provide visa sponsorship.

Qualifications

• Minimum 5 years' experience in pharmaceutical or chemical production.
• Thorough understanding of production processes and quality systems.
• Experience in working with interdisciplinary and multicultural teams.

Responsibilities

• Provide packaging process and material expertise.
• Participate in Joint process team meetings ensuring technical requirements are met.
• Support writing and review Annual Product Reports.

Skills

Fluent in English and another European language

Strong Project management skills

Strong communication skills

Expert in reviewing and writing technical reports

Problem-solving methodology

Multi-tasking and priority management

Education

Advanced university degree in life science or engineering

Job description

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.