How will you make an impact?
The Sr. Process Engineer will lead process engineering, operational excellence and capital projects related to the manufacturing of active pharmaceutical ingredients. The role will require the Sr. Process Engineer to lead projects independently, or as the leader of a cross-functional team. There will be extensive involvement in Engineering from conception through design; during equipment specification, startup, and validation as necessary for the projects. This position will lead, execute and coordinate the project activities of the Gallus internal project team and any other necessary resources, including but not limited to; outsourced engineers and designers
What will you do?
- Manage process engineering projects from conception through startup.
- Evaluate, develop, and manage the design and development of process based engineering projects.
- Analyze and propose solutions to technical problems; considers alternative projects.
- Collaborates with Manufacturing, Maintenance, Quality, EHS, and Financial organizations to develop project scopes, schedules, and cost estimates.
- Responsible to develop the project scope, budget and schedule into a Capital Appropriations Request (CAR, application for approval of funds) for capital projects.
- Coordinate internal/external validation resources to ensure project milestones are achieved.
- Maintain cost and schedule control on assigned projects from initial design through successful manufacturing of quality products.
- Ensures Certification through commissioning, validation and qualification of projects and current manufacturing operations.
- Advise Site Leadership on best courses of action on projects, technical matters and project economics. Provide regular communication up and down organization on status of projects.
- Represents Patheon in contracts with outside vendors, contractors, engineers, regulatory authorities, and consultants on a frequent basis during execution of a major project.
How will you get here?
- Bachelor of Science degree in Engineering required.
- Chemical, Electrical or Mechanical Engineering preferred.
- Civil, Industrial or other Engineering field acceptable with relevant work experience.
- Formal Project Management training and certification such as PMP, is preferred.
- 7+ years of Process Engineering/Project Management experience in the pharmaceutical manufacturing (or similar) industry.
- Solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing.
- Validation experience in a pharmaceutical environment is desired.
- Must possess a high level of proficiency in a technical core competency.
- Active participation in industry organizations such as ISPE is a plus.
- Excellent verbal and written communications skills with the ability to build and drive cross-functional teams.
- Strong customer focus and drive for results with strong problem-solving abilities.
- Capable of setting clear priorities, organizing work, and making quality decisions in a fast-paced business setting.
- Proficient with Microsoft Project.
- Experience in managing complex engineering projects through cross-functional teams.
- Knowledge and experience in a regulated environment to ensure regulatory compliance is achieved. GMP experience is preferred.
- Familiar with upstream and downstream bioprocess operations and equipment.
- Define process requirements and establish project design criteria based on engineering analysis and evaluation. Prepare detailed functional specifications.
- Experience in critical engineering tasks; forecasting, specifications, design guidelines, etc.
- Experience, training and certification in Operational Excellence (Six Sigma, Lean) is preferred.
- Responsible for the overall management and execution of assigned projects to meet the goals of scope, cost and schedule.
- Ability to analyze and review processes, process development work, and economic studies as required to develop the project alternatives and final developed scope.
- 5% - 15% Travel may be required.
- Risk of exposure to chemicals in a plant environment.
- Work around biopharmaceuticals, chemicals, plant utilities equipment and at construction sites.
At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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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, protected veteran status, disability or any other legally protected status.