Objectives/Purpose of Job:As a Senior Project Engineer, you will lead scope development, capital budget requirements, timelines, and the implementation of multi-year Site Master Plan (SMP) activities for complex business critical projects aligned with the Tampa Manufacturing site priorities.
Key Activities/Responsibilities:
- Develop and maintain a detailed project plan outlining key milestones, deliverables, timelines, and resource requirements for the SMP.
- Lead cross-functional teams in the identification, assessment, and prioritization of site infrastructure, facility and utility system upgrades, and process improvements needed to support current and future manufacturing operations.
- Lead individual capital projects (equipment or facility improvements) within the project portfolio from initial project definition and scope development, detailed project charter/scope, risk assessment, milestone schedule, budget, resource plans, user and functional requirements, conceptual design, detailed design, risk assessment, and equipment selection through start-up, commissioning, and qualification.
- Develop budgets, spending forecasts, resources, and timelines for the SMP, ensuring adherence to financial targets and project milestones.
- Facilitate regular project status meetings, provide updates to senior leadership, and escalate issues with recommendations necessary to ensure timely resolution and project success.
- Collaborate with and lead external vendors, contractors, and consultants to support the design, estimating, construction, and commissioning of facility upgrades and new infrastructure.
- Ensure compliance with applicable regulatory standards, including FDA cGMP guidelines, EU GMP Annex 1, and other relevant regulations governing pharmaceutical aseptic manufacturing facilities.
- Develop and maintain strong relationships with internal stakeholders and external partners to foster collaboration, transparency, and alignment throughout the project lifecycle.
- Prepare and deliver presentations, reports, and updates to senior management, site leadership, and key stakeholders on project status, risks, and opportunities.
- Develop SME knowledge in areas such as construction management, design, installation, commissioning and qualification, troubleshooting of aseptic clean rooms, process equipment, process flows, clean and black utility systems in a pharmaceutical site to industry standards.
- Drive application of industry standards and best practices.
Qualifications/Training:- BS/MS Mechanical Engineering, Chemical Engineering, Material Science, Chemistry, Physics, or related technical discipline. Advanced degree or professional certification (e.g., PMP) preferred.
- 8+ years in Engineering and/or Construction Management.
- Proven experience (5+ years) in managing large capital projects, preferably within the pharmaceutical or biotechnology industry, with a focus on facility design, construction management, and operations.
- Strong understanding of aseptic manufacturing principles, cleanroom design, HVAC systems, and regulatory requirements for pharmaceutical manufacturing facilities.
- Demonstrated leadership skills with the ability to lead cross-functional teams, drive consensus, and manage multiple priorities in a fast-paced environment.
- Excellent communication, presentation, and interpersonal skills, with the ability to effectively engage and influence stakeholders at all levels of the organization.
- Proficiency in project management tools/software (e.g., Planisware, Microsoft Project, Primavera) and MS Office suite.
Experience- Experience with facility renovation, construction, cleanrooms, clean and black utility systems, HVAC, manufacturing equipment start-up, and aseptic manufacturing operations.
- Strong background with FDA and EU regulations.
- Project management training or certification.
- Strong communication and interactive skills, capable of leading and directing project teams as required.
- Demonstrated ability to work across organizational boundaries.
- Excellent verbal, writing and computing skills. Familiar with MS Office, MS Project, CAD and Navisworks.
#LI-KF
This position may be available in the following location(s): US - Tampa, FL
Our US Benefit Programs Employee Benefits: Bausch + Lomb
