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Manager, Process Engineering - Capital Projects - Pharma Production, Michigan

Location
Trenton, Michigan
Posted
5 Sep 2022

Manager, Process Engineering - Capital Projects - Pharma Production.


Fast growing API Research and Manufacturing facility located in Michigan is seeking a Manager, Process Engineering - Capital Projects to join their Engineering team.


Company offers a generous compensation and benefits package, including RELO assistance and H1B Visa transfer for qualifying candidates.

POSITION SUMMARY: API Research and Manufacturing facility, located in Michigan, seeking a qualified Process Engineer & Operational Excellence (OpEx) Lead to join their Technology Transfer team.

KEY RESPONSIBILITIES.

  • Accountability of end-to-end process engineering responsibility for the product/products for commercial or development projects
  • Preparing unplanned and planned deviations for responsible processes and forming the investigation team.
  • Collaborates with Process Development (PD), Technology Transfer (TT), Operations, Quality Control (QC), and Quality Assurance (QA) in problem-solving activities, including deviation writing and CAPA closure.
  • Work with project and engineering teams to replace existing/modify or buy equipment's for continuous improvement or capacity enhancement
  • Functions as the technical interface with the Client focus on providing technical advice and support, engineering solutions, overseeing GMP runs in the plant equipment, analyzing production data to evaluate process performance, and writing production summaries.
  • Requires solid understanding of the manufacturing processes, GMP guidelines, site and corporate policies and procedures, hands-on experience, and complete understanding of production processes in the GMP environment as laid out. Willingness to work flexible hours and shifts when there is a need.
  • Drive Strategic projects to improve the process performance of the site and improve Right First Time performance
  • Ensure delivery of business process improvement initiatives through the implementation of predetermined/agreed synergies.
  • Benchmark and transfer best practices and procedures across all NA API sites to enable shared growth.
  • Drive ideation every year to optimize cost, productivity, and manage projects throughout the plant in all the departments.
  • Lead VSM on a timely basis across NA API sites for critical products to optimize lead-time and reduce/mitigate Non-Value Added (NVA) activities.
  • Drive automation at NA API sites with new systems and projects to reduce manual processes.
  • Identify improvement opportunities in processes- Lead projects to enhance Safety, Productivity, Quality, Cost, Delivery/Inventory of NA API Sites continuously
  • Support focused Site Improvement Teams & Daily Management Teams and showed improvements in chosen KPIs.
  • Support sites in preparing MIS report every month.
  • Use Lean and Six Sigma tools & methodology, ensure that the tools are used appropriately by team members, identify, and assist in removing barriers to projects.
  • Conduct Kaizen and KPI competition amongst the group, sharing OE best practices across various plants in the organization.
  • Facilitate Lean Six Sigma - White Belt, Yellow Belt, Green Belt, and Lunch & Learn' training Programs across locations to build a culture of continuous improvement.
  • Train teams in structured Problem-Solving techniques.
  • Ensure process data is being updated monthly; analyse manufacturing KPI performance for improvement and discussion with client. Coordinate the qualification of primary and secondary regulatory starting material suppliers for assigned projects.

KEY INTERACTIONS.

  • Internal: Technology Transfer; Process Development; Quality Assurance; Quality Control; Supply Chain; Facilities & Maintenance; Warehouse; EHS; Operation Excellence
  • External: Clients; Engineering companies and vendors

COMPLIANCE WITH POLICIES AND REGULATIONS:

  • Compliance with 21 CFR - Parts 210/211, EU Directives 91/356/EEC and ICH Q7.
  • Compliance with SOPs, batch records, forms, logs of use and quality agreements.
  • Recognize common sources of failure and improve documentation to reduce deviations and errors.
  • Work with Operations personnel to improve compliance.
  • Ensure work is in compliance with all state and federal regulations, including but not limited to OSHA, GMP, DEA, FDA, etc.
  • Assist in the formulation of corrective procedures when needed.
  • Use appropriate PPE while inside a manufacturing area.
  • Assume responsibility for safety and knowing the appropriate emergency procedures in case of emergency.
  • Know the location of SDS binders and understand how the guidelines pertain to employees.

EDUCATION/EXPERIENCE.

  • Bachelor's Degree in Chemistry or Engineering or similar pharmaceutical discipline is required. Master's Degree or PhD preferred.
  • At least 1-5 years of relevant work experience in the pharmaceutical industry.
  • Worked on LARGE CAPITAL PROJECTS
  • Demonstrated project management and technical leadership capabilities.
  • Confident management of internal and external stakeholder relationships.
  • Good written and oral communication skills.
  • Demonstrated teamwork skill and professionalism in all interactions.
  • Proven track record of successful technology transfer.
  • Working knowledge of process and desktop computers.

If you or folks you know are interested in exploring this amazing Engineering opportunity at a world renowned pharmaceutical CDMO, please contact Roger (reply here) to learn more or please pass this posting on to colleagues and your network! Relo $$ and Visa sponsorship offered.

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Details

  • Job Reference: 704417087-2
  • Date Posted: 5 September 2022
  • Recruiter: Masis Professional Group
  • Location: Trenton, Michigan
  • Salary: On Application