Process Engineering Equipment Qualification Lead

Process Engineer & Equipment Qualification Lead

This role will manage all equipment and system validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at WuXi Biologics facility in Louth.  The Process Engineering and Equipment Qualification Lead will provide equipment / system process engineering and validation expertise to support the facility start-up and routine commercial manufacturing.  The Process Engineering and Equipment Qualification Lead will be responsible for process engineering and validation oversight of - process equipment, laboratory systems and clean utility qualification.  The position is accountable for the timely and compliant completion of all Process Engineering and Equipment Qualification Lead related activities and milestones.

Responsibilities:

• Manage and lead a team of WuXi Biologics employees, contract process engineers and validation specialists.
• Build and oversee the budgets associated with process equipment, laboratory systems and clean utility qualification activities including both OpEx (routine) and Capex (project based).
• Own the PEV SOPs and plans associated with process equipment, laboratory and clean utility validation activities.
• Work closely with colleagues within the Engineering Department and cross functional departments (Manufacturing, QA, Automation and QC).
• Manage the generation and compliance of all equipment and system validation documentation e.g. risk assessments, validation protocols and reports and supporting documentation.
• Oversee the process for periodic review of validated equipment and systems and define the annual periodic review plans via the Siet Validation Masterplan.
• Collaborate across site functions, global functions and our clients to ensure equipment and system qualification activities are in line with new product introduction schedules.
• Serve as the site subject-matter expert on process equipment, laboratory systems and clean utilities validation activities during regulatory agency and client inspections.
• Lead all hiring needs for the team.
• Work closely with the extended team to ensure alignment of goals and objectives, and creating a continuous performance culture while supporting employee development.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Site PEV Lead.
• Will act as a role model for the Engineering function and also the wider organisation in adherence.

Requirements:

• Preferable 8 years experience of equipment, laboratory and clean utility systems, in addition approx. 3 years experience leading teams.
• Experience of process engineering and validation activities in a drug substance and/or drug product multiproduct facility is preferred.
• Proven people leadership and program management capabilities in a previous role.
• Experienced in the execution of commissioning and qualification of upstream and downstream bioprocess equipment.
• Experience in troubleshooting process engineering and validation challenges and providing solutions for GMP manufacturing.
• Experience operating in a fully automated Delta V facility
• B.Eng or B.Sc in Chemical / Process engineering or relevant scientific discipline is required.
• A postgraduate qualification in an engineering, scientific or managerial discipline would be advantageous.

Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Anna Fitzgerald on +353 83 859 2624 or send your CV to afitzgerald@berkley-group.com

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