Job Detail

Job Description

Manufacturing Associate IV participates in design and set up of large scale international cGMP manufacturing facility.  Will be involved in equipment review meetings, designing of functional specifications, equipment factory acceptance testing protocols, commissioning and validation.  In addition the role will be required to assist with writing of necessary SOP’s/protocols to support the start-up the plant.  The ideal person is highly detail-oriented with excellent documentation skills and exceptional troubleshooting abilities.  The MAIV is a lead associate position, expected to be an expert on multiple unit operations, have excellent technical understanding of the processes and equipment, and is skilled at leading, training, and supporting other associates or team members.  Some traveling will be required.

5 Shift work may be required

Qualifications

• Bachelor's degree in related field with 5-6 years Pharma/Biotech  professional experience


• Possesses a thorough understanding of the manufacturing process, including manufacturing support activities


• Has strong technical knowledge, including understanding relevant engineering and scientific concepts


• Understands basic biotechnology processing – purpose of major unit operations and microbial control concepts


• Fully understands cGMP requirements and applies these requirements to all situations, has validation knowledge


• Effectively communicates concepts and ideas, in addition to facts, both within the department as well as cross-functionally


• Actively pursues learning of required skills, new skills, and new equipment


• Communicates openly and honestly with others in both oral and written forms


• A very good level of English is mandatory