Senior Process Development EngineerApply Now
Location: Bedford, Massachusetts 01730
Employment Type: Contract
Senior Process Development Engineer
6 + Months
The candidate will support complex process development projects within the Engineering department responsible for developing and transferring processes for key development programs. The candidate will also be responsible for authoring and reviewing technical reports, protocols, technology transfer documents and CMC sections in regulatory filings. The candidate will serve as technical process representative on project teams and will also be expected to interact with internal and external stakeholders on a routine basis in the areas of QC methods development, Quality Assurance, Commercial Manufacturing, Supply Chain as well as Regulatory compliance groups. Specific focus areas include development of mixing, formulation, product transfer, filling, packaging and sterilization processes that results in product that consistently and reliably meets final product specifications.
- Prepares specifications for new equipment, prepares draft-operating procedures and supports validation to coordinate scale-up and validation activities.
- Identifies critical process parameters and input (raw) material attributes that must be controlled to achieve critical material (quality) attributes. Uses Risk assessments to prioritize process parameters and material attributes for experimental verification.
- Utilizes Design of experiments (DOE), risk assessment, and process analytical technology (PAT) as tools in the QbD process when appropriate.
- Establishes control strategies for the entire process that may include input material controls, process controls and monitors, design spaces around individual or multiple unit operations, and final product tests.
- Generates stability data according to ICH guidelines that demonstrates product meet quality attributes in line with user requirements and product shelf life.
- Coordinates required reports, specifications and technical documentation for project phase completion and Regulatory submission packets
- Transfers new equipment and processes to commercial manufacturing
- Perform other duties as assigned
Works on problems of diverse and highly technical scope requiring critical thinking and interaction with internal and external technical professionals. Exercises broad judgment within generally defined practices and policies. Requires interaction with multiple departments and coordination of multidisciplinary tasks.
- Bachelor’s Degree in Chemical, Biomedical Engineering or related science / engineering field. Master’s degree preferred and can be substituted for up to 2 years’ experience.
- 8+ years of process development, scale-up and process validation experience in drug / device industry.
- Excellent data analysis skills, and proficient in the use of statistical tools in problem solving.
- Thorough knowledge of Quality by Design concepts and principles
- Working knowledge of Design Controls from concept feasibility through technology transfer and maintenance stages
- Detailed knowledge of Process Validation requirements.
- Knowledge of quality systems Drug and Device (21 CFR 820 and 21 CFR 210/211).
- Experience with Medical Device Regulation ISO 13485.
- A very good understanding of the cGMP requirements of manufacturing processes for medical device or biopharmaceuticals.
- A good understanding of small scale model qualification and challenges faced during scale-up.
- Experienced in technology transfer to commercial manufacturing.
- Hands-on experience with process scale-up/process characterization.
- Experienced in authoring of CMC sections for regulatory filings.
Desired Experience, Knowledge, and Skills:
- Comprehensive knowledge of manufacturing equipment and processes in drug / medical device industry (Batch formulation, mixing of viscous gels, syringe filling, packaging and gamma sterilization).
- Proven professional communication skills – listening, oral and written.
- Demonstrated mastery of handling large sets of data including statistical analysis using software packages such as Minitab, JMP, SIMCA, etc.
- Detailed knowledge of multivariate analysis and DoE approaches.
- Working knowledge of Process Analytical Technology (PAT) tools
- Experience handling multiple tasks concurrently.
- Strong oral and written communication skills.
Trevor recruits for JVT's Life Sciences and Technology Practices where he specializes in finding, screening, and placing top-tier industry innovators at companies across multiple markets and verticals.
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