Location	Cork
Salary	Competitive
Ref. No.	PEBFxy
Duration	Permanent
Division	Engineering

Description

 

Main areas of responsibility:

•         During development and start-up phases of the facility, plan for and lead in collaboration with project and support functions the set up and qualify the production equipment.

•         Manage the preparation, implementation and review of work practices, standard operating procedures, training modules and compliance requirements during the start-up of the production area and ongoing operation of the production unit.

•         Lead and provide the technical expertise for all aspects of planned technical transfers.

•         Instill the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence.

•         Under the direction of the Production Leader, work closely with Pfizer Global Research and Development, Quality Assurance management in assessing all regulatory compliance issues specific to clinical manufacturing.

•         Plan , review and approve equipment commissioning plans and validation plans

•         Plan, review and approve factory acceptance tests. 

•         Participate in budget planning.  Communicate capital equipment needs, facility needs, staffing needs; and contract service requirements.

•         Identify and conduct colleague training for production colleagues.

 

 

Knowledge or Experience Required:

• Degree in Chemical Engineering, Biochemistry, Biotechnology, or related
• Demonstrated experience in Biotech facility operations or design is desirable but not necessary.
• Demonstrated experience in Project start-up/execution is advantageous
• Demonstrated experience of working in biotech pilot plant operation very desirable.
• Experience with technology transfer from R&D is an advantage.
• Excellent interpersonal and communication skills
• Strong ability to lead, challenge and positively influence in an interactive team environment.
• Demonstrated ability to deliver to site, team and personal objectives.
• Demonstrated ability to deliver to the Site Operations strategy.
• Demonstrated ability to work on own initiative and proactively respond to business needs.
• Demonstrated understanding and use RFT techniques and lean manufacturing concepts.