The BioProcess Engineer is responsible 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, help drive process
improvements, error proof the process, investigate deviations, 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. Complete requisite training and ensure all members of the manufacturing team are
current in their training requirements as well as all applicable policies and procedures related to the
job function. The successful candidate will take accountability to ensure all documentation is
complete and accurate, so issues can be addressed real time.
The BioProcess Engineer will be responsible for owning the process, planning ahead to avoid delays,
and good documentation practices. Participate in continuous improvement and operational
excellence projects to help drive efficiency, while error proofing the process.
· Produce clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs
· Support the product requirements to ensure that all products are produced according to plan.
· Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being
· Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities.
· Responsible for maintaining quality standards to meet cGMP requirements, CFR’s, and internal company policies directly related to the manufacturing process
· Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing
· Look for opportunities to implement operational excellence and continuous improvement
· Partner with Quality to ensure a quality and compliant manufacturing environment
· 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 · Excellent oral and written communication skills.
· 0-2 years of experience in biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish with:
· Working knowledge of FDA regulations and GMP systems
· Strong technical writing ability
· Proven ability to effectively lead and participate on teams
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.