Project Manager

Preferred – Primary Skills/Qualifications:

• Strong pharmaceutical project management skills and proven experience in having managed capital projects. Experience with Process Hazard Analysis (PHA), Process Safety Management (PSM), and Pre-Startup Safety Review (PSSR). Background in the use of the Stage Gate Process. Understanding of financial management as it relates to capital and expense spending and project cash flow forecasting. Understanding of regulatory, environmental, GMP and OSHA regulations.
• Familiar with the use of RPM (Project Capital System) and SRM (Purchase Order System). Pro-active in solving challenging project issues with the ability to develop creative solutions.
• Experience in total project delivery (from concept to validation and startup process). Leads the development of the capital project scope and objectives in support of the business strategy concerning clients and stakeholders.
• Exhibits project leadership and effective decision making throughout each project. Leads and promotes effective teamwork by engaging both Facilities as well as including key clients and stakeholders.
• Leads the scheduling, planning, control and effective coordination of all the parallel activities related to each project and maintains project schedule through minimal unanticipated schedule challenges.
• Possesses broad knowledge of the functional requirements of pharmaceutical facilities and engineering best practices, while ensuring that appropriate internal and external resources are incorporated into the project design and execution.
• Achieves a cost-effective, functional outcome with the use of design guidelines and standards, value engineering, life cycle costing and engineering best practices.
• Assures that the construction project and the finished facility are compliant with all applicable safety, regulatory, legal requirements.
• Achieves effective financial control through management of project scope, estimating, effective use of SAP, RPM, SRM, budget control tools, risk management, and project closeout.
• Achieves high customer satisfaction by delivering finished projects that are fully commissioned, qualified and ready for startup/occupancy and meets all requirements of stakeholders and stays within a predetermined schedule.
• Strong understanding of construction terminology and legal content of construction contracts and documents.
• Extremely proficient with closeout documentation standards.

Desired – Experience and Education:

• Bachelor’s degree in engineering (preferred in Chemical or Mechanical). EIT/PE License a plus.
• 10-15 to 25+ years’ experience managing pharmaceutical projects, especially with API and/or Pilot Plant Facilities.
• Experience managing multiple complex EPCMV projects ($10,000,000 – $50,000,000+).
• Demonstrated success leading multi-disciplinary and multi-functional teams and demonstrated strength in stakeholder management.
• Interpersonal / facilitation skills necessary to interface with and influence all levels of management.
• Experience in technical transfer of technology and concepts.
• Demonstrated Project Management expertise for design, construction, qualification and start-up involving all areas of Pharmaceutical Manufacturing, Pilot Plants, and Research Facilities.
• Hands on experience in the negotiation and management of contracts and agreements with engineering contractors, vendors, regulatory and government agencies.

Salary: Competitive Salary offerings

Benefits: Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, etc.

The Spear Group