Description:
Gabe, Inc.® is in need of a Senior Project Manager with experience in commercial, industrial, and life science construction; including qualification and validation of pharmaceutical equipment and facilities. The Senior Project Manager will be responsible for delivery of scope, schedule, and budget. We are looking for people to fill roles in this capacity for existing clients to Gabe Inc.®
Projects include upgrading of existing commercial/industrial facilities and equipment, as well as commercial/clinical process equipment and manufacturing facilities on site at a corporate headquarters of a Fortune 500 pharmaceutical company. Projects are supported by both Client’s full time staff as well as numerous contingent workers from other service suppliers.
Education:
- Successful candidates will have a bachelor's degree in chemistry, biology, physics, or other life science related studies.
- Engineering degrees will receive favorable consideration.
Certifications:
Experience:
- Minimum of 10 years of client facing pharmaceutical project management experience, managing projects >$100M.
- Process engineering and development experience a plus.
- Strong skills in Microsoft software (Word, Excel, Visio, Project) are required.
- Thorough knowledge of 21 CFR Parts 11, 210 and 211 is required.
- Experience with project budget development, cost tracking and schedule management is required.
Duties:
- This job includes leading cross functional teams from project inception through closeout following client’s Engineering Project Delivery model.
- Project scope and resource definition, preparation of justification and presentation to client senior management is within the senior project manager’s purview.
- Negotiation of implementation needs and resources with operations staff, complete responsibility for the safe and successful execution of projects with aggressive timelines.
- A broad spectrum of pharmaceutical process knowledge is required, and experience with industrial processes and equipment is a plus.
- Strong project management, supervisory, oral communications, and technical writing skills are required.
- Client will provide and require all necessary training for specific project requirements.
- Client will provide access (local and remote) to necessary logistical, planning and reporting tools.
Position will be responsible for schedule and budget management of capital projects, which may include:
- Lead cross-functional teams through all phases of the project lifecycle
- Manage scope, schedule, budget, and quality to ensure successful delivery
- Oversee procurement and vendor management as needed
- Ensure construction activities are properly planned and communicated to manage risk, ensure safety, and avoid disruption to ongoing business operations
- Budget development and cost/risk analysis, defense of budgets and participation in funding review
- Schedule development and construction coordination with facility shutdown windows
- Failure Mode Effects and Criticality Analysis
- Generation of RFP documents, contractor selection and management
- Quality/Validation protocol strategy development and document review
- Participation in facility schedule planning, coordination with facility staff to allow for minimal downtime
- Develop communication platform and provide regular status updates to corporate leadership and key stakeholders
- Management of change control, negotiation of requirements and strategy with corporate Quality Assurance staff
- Management of contractors and consultants
- Ensure turnover package documentation is properly assembled, transferred, and archived
- Provide leadership and direction to project team members.
- Foster collaboration, accountability, and continuous improvement.
- Additional Desired Skills:
- Piping specifications and mechanical knowledge
- Piping and instrumentation diagrams
- Strong engineering knowledge
- TrackWise, SAP, Trimble, PMWeb
- Design, construction and operation pharmaceutical plants
- Technical reports
- Effective interpersonal communications
- Proficiency with process modeling programs
- Ability to interact effectively with clients
Benefits:
- Gabe, Inc.®offers a competitive compensation and benefits package.
- Position is located at client site in client office/manufacturing space.
- Normal working hours are 8:00 a.m. to 5:00 p.m. Monday through Friday, however irregular working hours should be expected during project execution.
- Pay is hourly with overtime and is commensurate with qualifications and experience.
Thank you for your interest in Gabe, Inc.®
