The Operations Process Engineer II is responsible for: new product design transfers and commercialization, product line extensions, implementing process improvements, cost reduction initiatives, corrective actions, and statistical process monitoring. The position will represent Operation's process technical interest to ensure Quality by Design, optimal costs, and speed/service to market.
· Provide Operations technical support for new product technology transfer and product support activities (line extensions) to ensure successful introductions. This includes assisting activities such as design transfers, SOP writing, data collection and analysis, process qualifications, process validation, master validation planning, validation strategy, training subject matter expert, coordinating first builds, writing specifications, design control documents, etc.
· Identify Operations inputs for manufacturing processes from lab through production scale-up to meet product design specifications at various scales.
· Lead method implementation for process monitoring of critical to quality attributes, yields, and cost of goods.
· Execute sustaining engineering activities such as corrective action implementation and process improvements within the manufacturing environment to prevent product loss, increase efficiencies, and optimize process/cost.
· Apply statistics based experimentation, general engineering principle, process excellence principles, problem solving principles, and design for manufacturability during technical activities related to process changes and/or new product transfers.
· Write and execute study protocols, technical reports, Standard Operating Procedures (SOPs), validations, MVPs, batch records, design control and other documents as required with scientifically, statistically, and regulatory sound study designs.
· Participate on project teams and/or leading internal teams. Communicates activities across the organization. Interface with various departments to ensure processes and designs are compatible with the manufacturing environment, Operations strategy, and LifeCell's strategy. Utilize applicable business process in these activities such as Design Control and Product Commercialization Process.
· Partners with Quality and Regulatory Affairs, R&D, and Operations to ensure compliance of the manufacturing processes, provide support for regulatory filings, and ensure the scientific robustness of the process and raw materials
Position Qualification Requirements:
· Bachelors degree in Engineering or related field with at least 3 years of process engineering experience; or a Masters degree in Engineering or related field with at least 1 year of process engineering experience
· Experience with MS Office applications including Word, Excel, & Outlook
Other Position Qualifications
In addition to the basic qualifications listed above, the following other position qualifications are required:
· Experience assisting in operations technical support for new product technology transfer and product support activities
· Experience assisting in identifying Operations inputs for manufacturing processes from lab through production scale-up to meet product design specifications at various scales
· Experience with assisting in method implementation for process monitoring of critical to quality attributes, yields, and cost of goods
· Experience with process development using principles of design for manufacturability, lean, and Six Sigma in the medical device or pharmaceutical field
· Experience with use of statistical methods in experiment design, data analysis, development of robust manufacturing processes, validation, and process monitoring
· Experience with Quality System Regulations (QSR), Design Control, Human Tissue Regulations, and Sterilization Validation Standards
· Experience with root cause analysis methods
· Experience with technology transfer
· Demonstrated interpersonal skills to allow effective participation in project teams
In addition to the basic qualifications and other required qualifications listed above, the following preferred qualifications also exist:
· Experience with Six Sigma, Value Stream Mapping, Lean Manufacturing, Biological Products
The information listed in this Job Description is not a comprehensive list of all duties/responsibilities performed.
This Job Description is not an employment agreement or contract. Management has the exclusive right to alter this position guide at any time without notice.
Job: Quality Engineering
Primary Location: NJ-Branchburg
State or Province