Process Engineering Manager | The chemical engineer job board

When you’re part of the Thermo Fisher Scientific team, you’re doing important work, like helping customers find cures for cancer, protecting the environment, or making sure our food is safe. Your work will have real impact and you will be supported in achieving your career goals.

How are you going to have an impact?

This position is responsible for managing the planning, organization, staffing, control and direction of the Sterile Manufacturing Process Engineering Group at the Greenville, NC site. . Ensure that plans and decisions are developed and coordinated in a way that does not negatively impact systems, equipment and processes resulting in breakdowns or major breakdowns. Ensure compliance with state, federal and local regulatory agency codes and compliance with company rules and regulations. This Manager position will lead a team of engineers who support, direct, execute and coordinate project activities related to process equipment related to existing sterilization operations and/or for large strategic CAPEX projects and work with the team to ensure that the equipment is integrated into the installation. to meet cGMP and industry compliance guidelines.

What will you do?

  • Manage process engineering projects from conception to start-up. This includes projects/upgrades on existing business lines and large CAPEX projects.

  • Manage and provide ongoing development and guidance to a team of process engineers. Allocate and manage resources (people, budgets and equipment) in support of unit, site and corporate objectives. Provide advice to staff on technical and non-technical matters. Evaluate the need for reinforcement from an outside contractor. Take steps to transfer employees from one area to another when the need arises. Assign shift work as needed. Ask for additional help if needed. Develop performance plans and conduct appraisal reviews for all supervisors quarterly and annually. Develop and monitor individual goals for each subordinate.

  • Evaluate, develop and manage the design and development of process-based engineering projects.

  • Collaborates with manufacturing, maintenance, quality, EHS and finance organizations to develop project scopes, schedules and cost estimates.

  • Responsible for developing the project scope, budget and schedule in a Capital Appropriations Request (CAR, Funds Approval Request) for capital projects.

  • Coordinate internal/external validation resources to ensure project milestones are met.

  • Maintain cost and schedule control of assigned projects from initial design to successful manufacture of quality products.

  • Advise site management on best courses of action on projects, technical issues and project economics. Ensure regular communication from top to bottom on the status of projects.

  • Frequently represents Thermo Fisher Scientific in contracts with external suppliers, contractors, engineers, regulatory authorities and consultants during the execution of a major project.

  • Provide guidance to process engineers.

  • Support day-to-day operations by providing technical expertise and leading troubleshooting efforts.

  • Support engineering related technology transfer activities for new customers/products to ensure the product will work on existing equipment already in service.

How will you get here?

Education

Bachelor of Science in Engineering strongly preferred. More than 10 years of relevant experience can be considered an equivalency to education.

  • Chemical, Electrical or Mechanical Engineering preferred.

  • Field of civil, industrial or other acceptable engineering with relevant work experience.

  • Formal project management training and certification such as PMP is preferred.

Live

  • More than 6 years of experience in the pharmaceutical industry (or similar) with diploma.

  • Solid knowledge of current global good manufacturing practices (cGMP) in active pharmaceutical ingredients and/or manufacturing of finished pharmaceutical products.

  • Must possess a high level of proficiency in a basic technical skill, particularly in sterile aseptic manufacturing.

  • Active participation in industry organizations such as ISPE is a plus.

  • Excellent verbal and written communication skills with the ability to build and lead cross-functional teams.

  • Strong customer orientation and results oriented with strong problem solving skills.

  • Able to set clear priorities, organize work and make quality decisions in a fast-paced business environment.

  • Proficiency in Microsoft Project.

  • Experience managing complex engineering projects within cross-functional teams.

  • Knowledge and experience in a regulated environment to ensure regulatory compliance. GMP experience is preferred.

  • Familiar with upstream and downstream operations and equipment.

  • Define process requirements and establish project design criteria based on engineering analysis and evaluation. Write detailed functional specifications.

  • Experience in critical engineering tasks; forecasts, specifications, design guidelines, etc.

  • Experience, training and certification in operational excellence (Six Sigma, Lean) is preferred.

  • Responsible for overall management and execution of assigned projects to achieve scope, cost and schedule objectives.

  • Ability to analyze and review processes, process development work and economic studies required to develop project alternatives and final scope developed.

Physical

  • 5% – 10% Travel may be required.

  • Risk of exposure to chemicals in a plant environment.

  • Work around biopharmaceuticals, chemicals, plant utility equipment and on construction sites.

Thermo Fisher Scientific is an EEO/Affirmative Action employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, alumni status protected combatant, disability or other legally protected status.