Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionHow will you make an impact?The Thermo Fisher Scientific St. Louis site is a multi-product and multi-client biopharmaceutical site with manufacturing facilities for pharmaceutical products for both (pre)clinical trials and commercial applications. The Staff Engineer role is part of the Engineering team and reports to the Manager of Manufacturing Engineering. This role focuses on managing and supporting capital projects to enhance our manufacturing capabilities and ensure compliance with GMP standards.
What you will do• Manage contractors and capital projects up to $5MM.
• Develop and track scope, schedule, and budget for capital projects.
• Initiate, manage and close quality records related to capital projects.
• Drive closure of intermediate tasks on quality records to ensure departmental compliance and on-time completion.
• Author and Review GMP documents as required to support capital project objectives.
• Lead start-up and commissioning activities on capital projects.
• Ensure all capital projects comply with regulatory requirements, industry standards, and company policies.
• Collaborate with cross-functional teams including MSAT, PD, Quality, Operations, and Maintenance to ensure project alignment with business objectives.
• Conduct feasibility studies, prepare detailed project plans, and manage project timelines and budgets.
• Perform risk assessments and develop mitigation strategies to ensure successful project execution.
• Engage with business leadership as required for projects to attain business approval and ensure alignment of project deliverables with business objectives.
• Engage with customers and regulators as required for managed projects and areas of expertise.
• Drive adherence to site safety standards in delivering projects including applicable assessments of new facilities and equipment.
Education:- Bachelor's Degree or higher education in Engineering (Chemical, Mechanical, Electrical, Bio) and 5+ years experience, 8+ preferred.
- Associates Degree and 8+ years of related professional experience.
Experience- 5+ years of pharmaceutical industry experience or experience in a similar industry
- Past experience managing contractors and projects up to $5MM
- Experience authoring documents in a GMP setting.
- Experience working in a cleanroom.
- Prior experience working on commissioning and validation in a pharmaceutical setting.
Knowledge, Skills, Abilities- Knowledge of building codes and regulations.
- Understanding of regulatory requirements for pharmaceutical facilities.
- Excellent written and verbal communication
- Strong attention to detail
- Proficient with Microsoft Excel, Word, Outlook, Project and PowerPoint
- Proficient with AutoCad and Bluebeam
BenefitsWe offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
OtherRelocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
