Description
Our biotech client is going through a rapid expansion phase at their site in Germany and is looking to scale up from being a small production site. Our client is bringing new products on board and expanding current production and is looking for candidates with excellent experience to support them with setting up robust systems and processes.Job Description:
• Lead the development of systems and standards for:
o Automation and Controls standards,
o Hardware and software standards and platforms,
o HMI and downtime recording systems,
o CFR Part 11 Electronic Signature compliance for Electronic Batch Records,
• Develop automation concepts and drive implementation and training for the team.
• Review and develop alarm system specification and management.
• Review equipment specifications.
• Develop performance requirements
• FAT, SAT and Performance Qualification participation required.
• Build close relationships with Quality and Regulatory Affairs departments.
Educational / Experience Requirements:
• Outstanding experience in automation systems.
• Experience of PLC and BMS systems desired.
• Experience in a pharmaceutical or biotech environment essential.
• Previous success in developing and growing an automation department.
• Experience of developing and implementing new systems and processes.
• Experience of management of an automation department essential.
• GAMP5 implementation knowledge desirable.
• Excellent knowledge of GMP and FDA requirements.