Sr Biological Process Development Engineer at Teleflex in Maple Grove, MN
Position Summary o Developing and documenting manufacturing processes capable of producing pharmaceutical/biological products to meet established design specifications and cost targets in a timely and efficient manner. o Planning, coordinating, and executing process validations and transfer validated processes and equipment into production for commercial manufacturing. o Identify, specify, and coordinate development and sourcing of equipment, tooling, fixtures and component materials to produce product per design specifications Principal Responsibilities o Execute process characterization and investigations to establish process limits o Plan process development & validation activities for new products based on; projected product volume, project timelines, and COGS targets o Lead deveopment of manufacturing processes for new product from benchtop scale to commerical scale using Quality by Design approach (ICHQ8) o Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader o Generate documentation as outlined in the Process development process (e.g. FMEAs , protocols, reports, manufacturing records, and design transfer reports) o Direct PD technicians on creation of equipment files (IQP, test execution, and IQR), and completion of characterization and qualification builds o Conduct thorough analysis of test data including:
identification of outliers or non-normal data, generating data regression and factorial designs, general statistical analysis, and determining process capability o Conduct thorough Failure Analysis and Root Cause investigation and report results o Train PD technicians, production operators and manufacturing technicians o Identify, propose, and pursue COGS reduction and/or quality improvement opportunities which align with company business objectives o Coordinate, direct, and execute systematic process development activities such as; process characterization, DOE (to establish process limits), qualification and validation builds o Design and develop process flow and lay out to maximize production efficiency o Mentor PD Technicians junior engineering staff o Conduct process design, development, and implementation on multiple complex &/or significant company projects o Identify and pursue systemic improvement opportunities to maximize efficiency Education / Experience Requirements o BA/BS in chemistry, biochemistry, chemical engineering, or related science with a minimum of 5 years of biotechnology or pharmaceutical related process development experience. o Experience with processes or methods used in the pharmaceutical or biotechnology industry; FDA regulated industry experience
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
identification of outliers or non-normal data, generating data regression and factorial designs, general statistical analysis, and determining process capability o Conduct thorough Failure Analysis and Root Cause investigation and report results o Train PD technicians, production operators and manufacturing technicians o Identify, propose, and pursue COGS reduction and/or quality improvement opportunities which align with company business objectives o Coordinate, direct, and execute systematic process development activities such as; process characterization, DOE (to establish process limits), qualification and validation builds o Design and develop process flow and lay out to maximize production efficiency o Mentor PD Technicians junior engineering staff o Conduct process design, development, and implementation on multiple complex &/or significant company projects o Identify and pursue systemic improvement opportunities to maximize efficiency Education / Experience Requirements o BA/BS in chemistry, biochemistry, chemical engineering, or related science with a minimum of 5 years of biotechnology or pharmaceutical related process development experience. o Experience with processes or methods used in the pharmaceutical or biotechnology industry; FDA regulated industry experience
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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