About this role: Sr. Biological Process Development Engineer
Our client is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. Their portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care.
- 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.
- Planning, coordinating, and executing process validations and transfer validated processes and equipment into production for commercial manufacturing.
- Identify, specify, and coordinate development and sourcing of equipment, tooling, fixtures and component materials to produce product per design specifications
- Execute process characterization and investigations to establish process limits
- Plan process development & validation activities for new products based on; projected product volume, project timelines, and COGS targets
- Lead development of manufacturing processes for new product from benchtop scale to commerical scale using Quality by Design approach (ICHQ8)
- Establish project timelines, track progress, manage to the schedule and communicate project status to management and project leader
- Generate documentation as outlined in the Process development process (e.g. FMEAs , protocols, reports, manufacturing records, and design transfer reports)
- Direct PD technicians on creation of equipment files (IQP, test execution, and IQR), and completion of characterization and qualification builds
- 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
- Conduct thorough Failure Analysis and Root Cause investigation and report results
- Train PD technicians, production operators and manufacturing technicians
- Identify, propose, and pursue COGS reduction and/or quality improvement opportunities which align with company business objectives
- Coordinate, direct, and execute systematic process development activities such as; process characterization, DOE (to establish process limits), qualification and validation builds
- Design and develop process flow and lay out to maximize production efficiency
- Mentor PD Technicians junior engineering staff
- Conduct process design, development, and implementation on multiple complex &/or significant company projects
- Identify and pursue systemic improvement opportunities to maximize efficiency
- BA/BS in chemistry, biochemistry, chemical engineering, or related science with a minimum of 5 years of biotechnology or pharmaceutical related process development experience.
- Experience with processes or methods used in the pharmaceutical or biotechnology industry; FDA regulated industry experience
- Must possess the ability to understand, follow, and improve VSI documentation and quality system
- Demonstrated project management skills and ability to coordinate multiple projects simultaneously
- Demonstrated understanding of and capability to perform process qualification and validation activities
- Ability to organize, direct, and perform Process Validation activities including QbD, DOE, statistical analyses, process capability analyses and make data driven process decisions/determinations
- Leadership skills to train and mentor less experienced engineers
- Familiarity with Quality System methodologies and regulations associated with pharmaceutical and medical device industries
- Basic resource and budgetary planning skills
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- Certifications (optional)
- Job references (optional)
- Motivation Letter (optional)
Any questions remaining?
Your consultant, Kenneth McGreevy is happy to clarify anything about this vacancy. When reaching out, use the pub number:
Brunel USA - Boston