Randstad Quality Assurance in Libertyville, Illinois

Quality Assurance

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job details:

  • location:Libertyville, IL

  • salary:$80,000 - $90,000 per year

  • date posted:Wednesday, October 11, 2017

  • job type:Permanent

  • reference:22183

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description

Position: Senior BioProcess Engineer

The Senior BioProcess Engineer is responsible for organizing, running, sustaining, and continuously improving the manufacturing operations process at the plant/site. This individual will work on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.

Responsibilities of primary importance are to ensure the successful time-sensitive GMP manufacture and release of gene therapy products with minimal to zero deviations, promote a culture of quality and compliance while driving a sense of continuous improvement and operational excellence. Provide direction on the manufacturing floor to other staff members, resolve issues, escalate when necessary and provide leadership updates.

Other responsibilities include managing overall day-to-day manufacturing activities, supporting investigations, and working with other departments on all manufacturing to drive continuous improvements.

The Senior BioProcess Engineer will be responsible for driving the process, planning ahead to avoid delays, good documentation practices, and providing leadership for the team. This individual will participate in the hiring and training of key manufacturing personnel for both upstream cell culture and downstream purification and filling operations.

Responsibilities

  • Produce clinical and commercial material on an annual basis that meets the site's strategic objectives and is compliant with cGMPs

  • Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed

  • Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure.

  • Responsible for maintaining quality standards to meet cGMP requirements, CFR's, and internal company policies related to the manufacturing process

  • Provide hands on technical leadership to the manufacturing staff members

  • Look for opportunities to implement operational excellence and continuous improvement

  • Partner with Quality to ensure a quality and compliant manufacturing environment

  • Support Director of Operations to meet information requirements as needed for quality, compliance, and management reporting.

  • Assist the technical operations team to resolve any issues related to production

Required Education and Experience

  • Minimum B.S. degree in biochemistry, chemical engineering, bioengineering, or related technical field - A minimum of 5-8 years of experience in biopharmaceutical based GMP manufacturing operations including experience in cell culture, recovery, purification, aseptic fill/finish with:

  • Working knowledge of FDA regulations and GMP systems

  • Excellent oral and written communication skills. Strong technical writing ability required

  • Ability to motivate peers and staff, foster a culture of continuous improvement and operation excellence

  • Experience with 3rd parties (equipment vendors, and contract manufacturing insourcing/outsourcing) - Project management skill set with experience in strategic/tactical planning, team building, and meeting budgets.

Additional Requirements:

  • Approximately 10% travel required