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MTF Senior Process Engineer in Jessup, Pennsylvania

Overview/Risks

The Senior Process Engineer is responsible for all aspects of new product transfers, process development, new technology integration/innovation, and process improvement projects for the assigned processing unit(s). Implement operating standards for processing. Implement processes and products and recommend7 ways to improve processes and products. The Senior Process Engineer is assigned responsibilities to engineering areas and will initiate projects, define critical steps and resources, and develop practical and thorough solutions to complex problems. This position will help develop modifications to processes and products. The Senior Process Engineer requires limited direction, is self-organized and can make independent decisions. The Senior Process Engineer may direct the Process engineering function and may be responsible for the support, guidance workload and development of his/her direct reports.

Responsibilities

  1. Responsible to independently understand the processes in the processing unit and maximize the efficiency and quality of existing processes.

  2. Lead cross-functional process improvement and business support teams.

  3. Regularly interact at a detailed technical level and collaborate with R&D to develop new product and equipment for processing, from feasibility testing through process implementation and monitoring.

  4. Utilize planning techniques to ensure a seamless transition from R&D to manufacturing of new products and processes.

  5. Develop and execute validation protocols (IQ/OQ/PQ) to assess process capability, analyze data using statistics, and generate required compliance documentation.

  6. Develop and execute studies to establish equipment, product, or process specifications. Generate statistical summaries and reports from collected data.

  7. Responsible for identifying, researching, and integrating new technologies applicable to MTF processing environment.

  8. Investigate, integrate and evaluate the impact of new process introductions.

  9. Assess and implement process changes as required by internal or external customer request, in response to processing quality issues, or design changes.

  10. Participate in or lead process risk analysis activities (FMEA) to support new or existing processes.

  11. Implement change controls and ensure processing documents/procedures/specifications are complete, accurate, and current.

  12. Perform investigations and root cause analysis for NCR’s. Implement corrective actions.

  13. Participate in processing investigations/CAPA/complaint resolutions to identify process improvements.

  14. Develop training plans and facilitate technician training

  15. Enter clean room periodically to qualify and audit processes

  16. Provide verbal and written project updates to individuals and groups as necessary.

  17. May manage the daily supervision of direct reports, provide guidance through performance management, development plans, and coaching. Perform functions of year end merit and bonus activities

  18. Lead special projects and perform additional duties as assigned

Qualifications

MINIMUM QUALIFICATIONS

Education: Bachelor's Degree

Years of Experience: 5 - 7 years

Other: Minimum 5 years of experience in manufacturing environment (GMP or GTP).

Specific Licenses and/or Certifications: Other

Other: N/A

Specialized Knowledge, Technical Skills, and Abilities:

  • Demonstrated success in project planning, project execution, and project completion.

  • Strong critical thinking

  • Strong interpersonal skills

  • Thorough working knowledge of statistics

  • Ability to work independently

  • Strong written and verbal communication skills and ability to work within a multi-functional team environment.

  • Proficiency in Microsoft Office and Project

  • Proficient in programming CNC equipment (Jessup only).

PREFERRED QUALIFICATIONS

Education: Bachelor's Degree

Years of Experience: 5- 9 years

Other: Familiarity with risk management tools.

Specific Licenses and/or Certifications: Other

Other: N/A

Specialized Knowledge, Technical Skills, and Abilities:

  • Experience leading Lean Six Sigma projects

  • CAD design – Solid Edge, Solid modeling

  • Cryogenic processing (Edison only – Dermis and Trinity processes)

  • Isolator technology (Edison only – DBX processes)

  • Statistical analysis using Minitab

  • Factory/Site Acceptance Testing (FAT/SAT)

  • Six Sigma: DMAIC and DFSS

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Job Location US-PA-Jessup | US-NJ-Edison

Type Full-Time

Category Engineering

Shift 1st Shift

Job ID 2021-5615

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