As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
What will you do?
- With a solid knowledge of global current Good Manufacturing Practices (cGMP) in active pharmaceutical ingredients and/or finished pharmaceutical manufacturing, you will be a Subject Matter Expert (SME) for engineering projects and support.
- You will manage complex engineering projects through cross-functional teams and leverage experience in the biopharma and cell therapy R&D labs as well as in the cGMP manufacturing environment
- Evaluate, develop, and manage the design and development of engineering projects from conception/construction through startup.
- Work with end-users and scientist in selection, installation and commissioning of lab and manufacturing equipment and processing systems.
- Analyze and propose solutions to technical problems; considers alternative projects.
- Collaborate with Operations, Facilities, and Quality, EHS, and Financial organizations to develop project scopes, cost estimates, and schedules.
- Be responsible to develop the project scope, budget and schedule into a Capital Appropriations Request (CAR, application for approval of funds) for capital projects.
- Manage your projects to be on time, on budget and on scope.
- Ensure certification and functionality through commissioning, validation and qualification of projects and current laboratory operations.
- Help govern site electronic systems use, organization, communication, and workflows
- 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.
- Represent Company in contacts with outside vendors, contractors, engineers, regulatory authorities, and consultants on a frequent basis during execution of a major project.
- Maintain and/or create necessary engineering documentation (Facilities/Engineering standards and specs, FRS, URS, DDS, drawings, data, software/electronic systems, etc.) for responsible equipment.
- Define process requirements and establish project design criteria based on engineering analysis and evaluation. Prepare detailed functional specifications.
- Responsible for the overall management and execution of assigned projects to meet the goals of scope, cost and schedule.
How will you get there?
- Bachelor’s Degree in engineering required, preferably in Chemical, Bio, or Mechanical Engineering.
- Certified Pharmaceutical GMP Professional highly desirable
- 5+ years of experience as a process engineer in the cGMP pharmaceutical industry with design, construction, and processes experience is our ideal candidate.
- Familiar with bioprocess and cell therapy operations and equipment.
- Knowledge and experience in a regulated environment to ensure regulatory compliance is achieved. GMP experience is preferred.
- Experience in critical engineering tasks (forecasting, specifications, design guidelines, etc.)
- Validation experience in a pharmaceutical environment is preferred.
- Proficient with CAD and Microsoft Office applications including Microsoft Project.
- Must possess a high level of proficiency in a technical core competency.
- Active participation in industry organizations such as ISPE is a plus.
Knowledge, Skills, Abilities:
- Excellent verbal and written communications skills with the ability to build and drive cross-functional teams.
- Experience, training, and certification in Operational Excellence (Six Sigma, Lean) is preferred.
- 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.
- Ability to analyze and review processes, process development work, and economic studies as required to develop the project alternatives and final developed scope.
- Ability to travel 5% - 15% as required
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
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.