The PositionResponsible for complete Project Management (personnel & processes) for the site processes in the assigned area for a new facility/production line. Manages all aspects of the Project from conception through completion within scope, cost, quality & schedule requirements. Leads & manages the Project Management team so that stated project objectives & solution requirements are met in compliance with company procedures & standards.
RelationshipsReports to Project Director or Site Vice President.
Essential Functions- Responsible for defining overall scope, establishing detailed RFP for obtaining proposals from all required consultants (engineering, construction, cost estimations (IPC costs), equipment vendors, etc.)
- Ability to create detailed business case, & present to senior management within NN & IPG for funding of project
- Effectively organize & manage multi-disciplined project team to ensure successful completion of all project deliverables - including hiring, goal setting, performance management, employee development & engagement
- Manage major milestones, schedules & monthly cost plans through the Clarity & PEM processes
- Provide periodic project status to STC including risks/mitigations, financial updates, short/long term project outlook, etc.
- Responsible for managing project change control to ensure project remains within defined scope, budget & schedule
- Extensive collaboration with other sites within NN & external stakeholders to gain best practices & equipment specifications
- Responsible for adherence to mechanisms for monitoring project progress, intervention & problem solving with other line managers or personnel
- Assist with any training required of personnel supporting the project
- Ensure all facets of the project lifecycle align with expectations set forth by the STG &/or project owner, such as installation, troubleshooting, qualification & validation of equipment
- Lead, & coach Subject Matter Experts (SMEs) to ensure a high performing collaborative team environment
- Follow all safety & environmental requirements in the performance of duties
- Other duties as assigned
Physical RequirementsAbility to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role.)
Qualifications- Bachelor's Degree in Engineering, Economics, Business Administration, or other relevant disciplines from an accredited university (required).
- Minimum of nine (9) years proven leadership & project management in a manufacturing facility, including :
- Capital Investment Projects with major projects more than $20M required
- Advanced Project Management competencies obtained through relevant PM training or experience preferred
- Minimum of five (5) years of experience in pharmaceutical or biotechnology environment preferred
- Required experience:
- Product/Process Transfer Projects
- Change Management Projects
- Preferred Experience and Skills experience:
- Knowledgeable in core work processes & GMP concepts
- Understanding of complicated product documentation & standard operating procedures with attention to high-level concepts
- Demonstrates functional/business understanding as well as superior written & oral communication skills preferred
- Extensive knowledge of project management including the ability to create work plans & detailed project schedules preferred
- Proficient in problem solving, negotiation, conflict management & interpersonal skills preferred
- Ability to act as project lead & lead cross functional project teams in the development & implementation of projects preferred
- Ability to influence others on objectives & projects outcomes preferred
- Basic understanding of contractual documents preferred
- Ability to read/review design drawings (CAD) with a basic understanding of P&ID, HVAC & Electrical systems preferred
- Thorough understanding of technical documents such as URS, SAT, FAT & Validation Protocols preferred
- Proven project management experience with direct management of multiple projects simultaneously preferred
- Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems preferred
- Initiative & ability to function independently or within a team preferred
- Good judgment in decision making as well as good leadership skills preferred
