Quanta Consultancy Services Ltd
Process Engineer - Ohio, US - 12 months
This is a fantastic opportunity for a Process Engineer to join our major, global pharmaceutical client on their latest new-build project based in Ohio, this is a large-scale greenfield capital project and investing more than $1bn.
Responsibilities
Provide engineering and technical support for upstream, downstream, and drug product processes within a Cell and Gene Therapy environment. Act as an Owner’s Representative during commissioning, qualification, and operational readiness activities. Support day-to-day operations, troubleshooting, and process optimization to ensure manufacturing readiness. Collaborate with cross-functional teams (manufacturing, quality, validation, engineering) to drive project success. Ensure compliance with cGMP, regulatory, and safety standards across all activities. Prepare and review technical documentation, reports, and protocols as required. Provide shift coverage support, including potential second shift and weekend work to maintain continuous processing operations. Skills & Experience
Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, Biotechnology, or related field. 3+ years of relevant process engineering experience in pharmaceutical, biotechnology, or cell & gene therapy manufacturing. Strong knowledge of upstream (cell culture/fermentation), downstream (purification/filtration), and/or drug product manufacturing processes. Experience supporting commissioning, qualification, and start-up (CQV) activities. Familiarity with cGMP regulations and quality compliance requirements. Excellent problem-solving and troubleshooting skills in a fast-paced environment. Ability to support extended hours, including second shift or weekends, as needed. If this role is of interest, please apply now!
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Provide engineering and technical support for upstream, downstream, and drug product processes within a Cell and Gene Therapy environment. Act as an Owner’s Representative during commissioning, qualification, and operational readiness activities. Support day-to-day operations, troubleshooting, and process optimization to ensure manufacturing readiness. Collaborate with cross-functional teams (manufacturing, quality, validation, engineering) to drive project success. Ensure compliance with cGMP, regulatory, and safety standards across all activities. Prepare and review technical documentation, reports, and protocols as required. Provide shift coverage support, including potential second shift and weekend work to maintain continuous processing operations. Skills & Experience
Bachelor’s degree in Chemical Engineering, Bioprocess Engineering, Biotechnology, or related field. 3+ years of relevant process engineering experience in pharmaceutical, biotechnology, or cell & gene therapy manufacturing. Strong knowledge of upstream (cell culture/fermentation), downstream (purification/filtration), and/or drug product manufacturing processes. Experience supporting commissioning, qualification, and start-up (CQV) activities. Familiarity with cGMP regulations and quality compliance requirements. Excellent problem-solving and troubleshooting skills in a fast-paced environment. Ability to support extended hours, including second shift or weekends, as needed. If this role is of interest, please apply now!
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