Project Coordinator

Main Responsibilities & Accountabilities

Design Phase

• Coordinate project governance meetings, agendas, minutes, action logs and decision registers.
• Manage document control processes for URS, specifications, drawings and workflows.
• Coordinate third-party partner onboarding, confidentiality agreements, training requirements, site access and document requests.
• Support creation and tracking of project purchase requisitions and purchase order approvals.
• Maintain project stakeholder communications and reporting systems.
• Support review and approval routing for project documentation.

Procurement (Build) Phase

• Administer contractor and supplier onboarding and maintain approved vendor records.
• Track purchase orders, invoice approvals, contract milestones and budget reporting.
• Coordinate equipment delivery schedules, contractor access, training compliance and badging.
• Maintain turnover documentation, submittals, drawing packages and vendor records.
• Support construction meetings, punch list tracking and action item management.

Commissioning, Qualification & Validation (CQV)

• Maintain readiness trackers, exception logs, punch lists and document archives.
• Coordinate third-party CQV resources, training compliance and system access.
• Support SAP, MES and business system master data readiness activities.
• Ensure controlled documentation is inspection ready.

Operational Readiness & Start-Up

• Transition into Production Coordinator responsibilities.
• Coordinate staffing plans, training curricula, qualifications and workforce readiness.
• Support manufacturing system readiness, material setup and process order preparation.
• Maintain SOP, batch record, logbook and document control processes.

Licensure (Manufacturing Department Management)

• Convert planned orders to process orders and coordinate production administrative activities.
• Support inventory management, material coordination and physical inventory activities.
• Track batch disposition, order closure and departmental records.
• Coordinate quality sample submissions and GMP documentation.
• Provide administrative management support related to bargaining unit staffing: Attendance, schedules, vacations, interdepartmental movement, etc.
• Ensure the completion and closeout of the manufacturing process orders for each batch. Includes release tracking, closing orders, disposition management (ATD/NOD).
• Support audits, inspections and continuous improvement initiatives.
• Support project closeout activities.

Education

Associate’s degree, Bachelor’s degree preferred. Demonstrated strong performance in GMP manufacturing environment acceptable in lieu of preferred education experience.

Experience

5+ years manufacturing experience in pharmaceutical, biotechnology, or biological industry. Administrative or Manufacturing experience in a high volume/high stress environment. Experience in a Union manufacturing environment will be considered a plus. Proficient in Microsoft Office applications and relevant business information systems. SAP experience preferred.

Competencies

Priority setting, time management, interpersonal savvy, action oriented, exceptional communication skills, detail oriented, able to deal with ambiguity and problem solve, organizational and functional/technical skills.

Compliance and Safety Focus

Strong understanding of regulatory, quality, and safety standards.

Resilience

Maintains technical clarity and effectiveness under pressure, successfully navigating uncertainty and dynamic project conditions. Should be flexible and adapt well to change.

Environment

Candidate must be able to wear clean room garments and personal protective equipment and meet cGMP gowning requirements to work in manufacturing environments. Work environment may include navigating a large facility as well as operating in a production office. Exposure to various temperatures, hazardous chemicals, and potential bloodborne pathogens. May be required to work overtime and extended hours to support business needs. Some travel (<10%) may be required.