The Process Engineer in collaboration with Commercial Operations, recommends, develops and implements process improvements and controls:
- Designs and modifies processes to cost effectively produce products which meet critical product attributes. Performs experiments to screen critical process control factors. Uses experimental design techniques to develop robust processes.
- Through experiments, literature searches, and internal and external interactions, identifies new technologies aimed at improving manufacturing efficiencies, manufacturing capacities and product quality.
All Engineering activities must be in compliance with FDA, GMP, ISO and Corporate Quality System regulations.
- Ensures processes and procedures are in compliance with regulations. Experience with lean manufacturing and principles including statistical analysis, variation reduction, waste reduction, customer evaluation, and has general knowledge of other related disciplines.
- Make use of appropriate technical skills and tools, such as SPC, hypothesis testing, capability studies, Gemba walks, and “hands on” analysis, to perform in depth analysis, determine root cause, and identify corrective actions
- Identification of cost reduction opportunities and perform assessment based on impact and effort for prioritization
- Inspects performance of equipment and processes to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
- May incorporate inspection and test requirements into the production plan.
- Develops / improves manufacturing processes that are applicable to statistical process control, and may develop those techniques.
- Utilizes project management skills to drive continuous improvement initiatives, including lean manufacturing, risk assessments, and cost/benefit analysis
- Manages project through required regulatory approvals
- Leads teams and collaborate with multiple levels and cross-functional areas for effective project execution
- Conducts regular project reviews to assure accomplishment of key results.
- Communicates progress, status, and issues to management.
- Other projects and activities as required
The job requires the ability to act on problems of diverse and highly technical scope, requiring critical thinking and interaction with internal and external technical professionals. The position exercises broad judgment within generally defined practices and policies and exercises analytical decision-making abilities.
No direct reports, however, must be able to participate in multi-disciplined project teams and manage vendors, contractors and consultants as required.
- Bachelor of Science Degree in Chemical Engineering, Mechanical Engineering or related discipline
- Minimum of 5-8 years or advanced degree with 3-5 years of relevant experience with process development and continuous improvements in medical device / pharmaceutical manufacturing environment
- Knowledge and experience with the US/EU process validation requirements for commercialized products
Desired Experience, Knowledge, and Skills:
- Knowledge of manufacturing equipment and processes in medical device and pharmaceutical industry
- Knowledge and understanding of Quality by design, technology transfer and process validation in the medical device and pharmaceutical industry.
- Experience with formulation and filling processes for viscous solutions
- Knowledge of Terminal sterilization process development and validation (Gamma, Steam, EtO)
- Understanding of process controls
- Proven professional communication skills – listening, oral and written
- Strong analytical and organizational skills
- Proactive problem definition and creative problem solving skills
- Experience handling multiple tasks concurrently
- Excellent data analysis skills, and proficient in the use of statistical tools in problem solving
- Knowledge of quality systems
- Experience with Medical Device Regulation ISO 13485.
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.