Project Manager Engineering and Validation
Civica is a rapidly growing and entrepreneurial nonprofit generic drug company created in September 2018 to reduce and prevent drug shortages and the price spikes that can accompany them. Its mission, as driven by its governing board of hospital systems and philanthropies, is to make quality generic medicines accessible and affordable to everyone.
Civica is improving patient outcomes and reducing healthcare costs.
Today, more than 50 health systems have joined Civica. They represent over 1,200 hospitals and over 30 percent of all U.S. hospital beds. Civica has also begun to supply the Veteran’s Administration, the Department of Defense, and the U.S. Strategic National Stockpile essential medicines.
In less than two years, Civica has secured 40 different medications and provided over 2 million vials of sterile injectable essential medicines to the Strategic National Stockpile.
Civica is building a 100 million dollar state-of-the-art manufacturing plant. Join us to help serve patients!
We are seeking a highly motivated Project Manager who is interested in joining our fast-paced, dynamic start-up environment. The Project Manager; Engineering and Validation is responsible for the overall project management function for the Civica Petersburg facility, providing leadership, coordination, and management of the critical projects from a design, implementation, delivery & qualification perspective. You must have a willingness to perform "hands-on" work in a dynamic, team-oriented work setting. Incumbent provides technical expertise on Construction, Start-up and Compliance standards and processes to team members; and provides input on schedule strategy to key business leaders.
- Utilizing project management principals & tools; this role will work with external A&E, construction, and sub-contact firms to confirm and manage project schedules. Internally the role will be responsible for pulling in critical dates from construction activities and developing an integrated schedule from FAT, SAT through qualification, as well as R&D and regulatory filing tracking.
- Lead project scheduling and weekly review meetings, key milestone close out meetings and facilitate project update meetings throughout the execution phase of the project.
- Establishes budget baseline and initiates project financial tracking. Monitors the project budget and maintains all milestones in alignment with site Project Review Board so that appropriate invoicing and revenue recognition can be accomplished in a timely manner.
- Establish full project plans, including timeline, critical path assessment, risk assessment, contingency planning, mitigation planning, communication planning, contact listing, and confirm scope capture during planning phase of a project.
- Controls and monitors project progress to ensure that milestones are accomplished on time and communicated as needed.
- Evaluates and adds details to project plan initiated during the proposal in conjunction with all participating departments for confirmation at the initiation of the project. Any changes or additions to the schedule will be first verified against the master schedule and then agreed upon with the team.
- Work closely with site Operations, Validation and Quality management to manage and prioritize the project schedule as it relates to deliverables and deadlines. Candidate with construction, start-up and/or commissioning, qualification, and validation experiences preferred.
- Bachelor's degree from an accredited college/university (a degree in life sciences, engineering or medically related field is preferred), Project Management Professional (PMP) certification is a plus.
- Minimum 3 years project management experience with relevant experience in biotechnology, life sciences, pharmaceutical or medically related field. Recent college graduates will be considered if they possess strong technical capabilities and an ability to articulate a relative project management mindset.
- Experience in working in a cGMP environment, with FDA & DEA experience is preferred.
- Demonstrated experience in complex strategic planning, project execution, and resource management desirable.
- Experience in successfully coordinating across several complex functions to ensure comprehensive and consistent planning.
- Proficiency in project management principles, practices, and tools such as MS Project (Gantt charts) is required.
Experience with the preparation of reports and/or presentations/communications via presentation tools such as PowerPoint, project dashboards and written reports.
Salary DOE, excellent benefits.