GMP, Senior Project Manager, Infrastructure/Capital Planning

3 weeks ago

Billerica, United States Randstad USA Full time

In this position, the ideal candidate will work independently to lead cross-functional project teams through all phases of Infrastructure-Utility, Lab-Office and GMP Manufacturing projects-from scope development, design, CQV and close-out. This position will consistently deliver projects that meet all stakeholder requirements and are fully commissioned, qualified and ready for start-up / occupancy.

Key Responsibilities / Essential Functions

  • Use project planning tools and management principles to initiate, design, develop, and evaluate plans for assigned projects and hold projects on budget and schedule coordinating parallel activities.
  • Lead team members during project execution including Manufacturing staff, Facilities staff, multiple outside vendors and contractors. Project Management responsibility for projects in the $500K- $10M range.
  • Drive alignment on scope and project status through transparent, timely, and clear verbal and written communications to teams, stakeholders and appropriate levels of the organization of both technical and non-technical topics.
  • Partner with Purchasing to prepare bid packages for design and construction contracts; effectively lead the negotiation, award and management of contracts and agreements with AE firms, vendors, construction contractors, regulatory and government agencies.
  • Prepare project estimates for design, equipment, installation, labor, materials, and other related costs.
  • Develop, manage and maintain up-to-date MS Project schedules inclusive of all critical milestones, key interdependencies and resource constraints, applying appropriate project scheduling techniques.
  • Utilizing MS Project schedules and project estimates, develop cash flows and track project spend on monthly basis, preparing monthly reports to inform management on project progress.
  • Drive the execution of external design partners and construction firms to deliver the right scope at the right time. Set clear expectations across all phases of partner onboarding including: Scope/RFP generation, bid reviews, contract execution, and contractor onboarding. Approve, manage, coordinate and oversee development of project design documents. Select A/E firms to perform engineering design. Coordinate and lead team review of designs/deliverables and document decisions accordingly.
  • Manage and oversee project contract work both in engineering and construction. Inspect or direct the inspection of work to ensure conformance to design drawings, specifications, schedules, and safety regulations. Ensure contractors receive site orientation and training and that all state/local code requirements, building permits, inspection and project close-out processes are followed.
  • Establish clear performance and acceptance criteria, draft and execute project commissioning plans and ensure that projects and equipment are rigorously designed and tested to this criteria. Drive effective project turnover from the engineering function into the business owners.
  • Achieve effective financial control through management of project scope, estimating, risk management, and project closeout. Negotiate with contractors and suppliers to keep projects within budget while obtaining excellent value. Manage the review and approval of contractor RFI’s, submittals, and change requests.
  • Provide project management reports and presentations. Monitor project status and execution.
  • Incorporate safety into all aspects of projects; construction safety management, site security, environmental control, hazardous materials management, fire protection and life safety systems.
  • Utilize effective meeting management principles to drive results oriented project meetings including development of clear agendas, capturing and timely distribution of minutes, & proactive follow-up of assigned tasks.

Basic Qualifications

  • 4 year BS degree in engineering is required. Advanced degree in industry relevant discipline or MBA is a plus.
  • Minimum of 10 years demonstrated Project Engineering & Management experience leading cross-functional project teams for design, construction, commissioning & qualification, and start-up with a proven track record of on-time & on-budget performance for complex projects related to Pharmaceutical Manufacturing Facilities.
  • Strong technical skills in pharmaceutical equipment, utilities systems, and facilities engineering preferred. Basic understanding of building and equipment automation capabilities and industry best practices.
  • Demonstrated working knowledge of MS Office suite of software tools (PowerPoint, Excel, Word), as well as, demonstrated competency in the use of MS Project.
  • Strong knowledge of engineering standards and all applicable regulatory requirements including: Building Codes, Factory Mutual, Environmental, GMP/GLP, OSHA and ADA.
  • Strong understanding of Quality Systems. Solid understanding of cGMPs. Able to interpret CFRs in establishing current practices.
  • Demonstrated skills in basic technical report writing: Engineering studies, user requirement specifications, commissioning documents.
  • Excellent leadership, interpersonal, influencing, organizational and time management skills.
  • Excellent oral & written communication skills.
  • Demonstrated sound judgment, good business acumen and strong analytical skills.
  • Ability and willingness to accommodate flexible scheduling including off-hours and week-end work.
  • Travel 5-10 percent.

Other Requirements

  • This individual should be a self-starter with strong leadership, interpersonal, organizational and technical skills, with the capability to work both independently and in a team environment. Strong analytical and communications skills are critical.
  • Project Management education, training, and/or PMP certification is desirable.
  • Affiliations with relevant industry associations, such as ISPE, PDA, etc.
  • Knowledge of and experience with lean concepts and tools.

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