CQV Project Manager

About the role

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager of CQV to join our team at our office located near Elkton, Virginia.

Responsibilities

• Perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients.
• Follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
• Interface directly with IPS clients in the delivery of projects, including routine communications, leading project meetings, tracking, and reporting project metrics (financial and deliverables).
• Self-direct and direct the assigned project team, maintain positive client relationships, manage and perform standalone commissioning services for non-FDA-regulated clients.
• Directly responsible for the successful delivery of commissioning and compliance projects to IPS’ clients.
• Lead multiple concurrent small, mid-sized, or large projects on behalf of IPS.
• Ips point of contact to the client for overall project delivery.
• Runs meetings, communicates status and project issues, frequently checks in with client representative(s), and facilitates general project coordination activities.
• Coordinates project activities with the IPS Project Lead.
• Performs work to meet IPS budget requirements and quality standards.
• Provides consistent, complete, and timely feedback and reports to IPS clients or management on project status and issues.
• Develops project schedules, deliverable tracking reports, scope adjustment notices, etc.
• Supports, trains, mentors, and guides commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.
• Affords assistance or takes lead in proposal development, including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.
• Writes and manages others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
• C/Q/V Master Plans
• Commissioning Forms
• C/Q/V Protocols and Summary Reports
• Standard Operating Procedures
• Impact Assessments
• Specifications (URS/FRS/DDS)
• FATS/SATs
• Performs and manages others during field/site activities, including, but not limited to, the following:
• Attends and witnesses FATs and SATs as a representative of IPS clients.
• Execution of commissioning forms and witnessing of vendor start-up and testing.
• Execution of C/Q/V protocols.
• Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
• Compiles data packages and prepares reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
• Responsible for deviation investigation and resolution of problems and issues encountered during field execution activities.
• Audits project deliverables to assure compliance with established standards.
• Reviews the work of the assigned project team.
• Ensures the quality of the IPS project work.
• Acts as an IPS representative for developing new opportunities and continues to support repeat business.
• Demonstrated/recognized areas of expertise by industry (Sterile, OSD, Biotech, Medical Device), by equipment/systems (lyos, autoclaves, packaging, compression/encapsulation, etc.), or by validation activity (process, cleaning, CSV, methods, etc.).
• Provides working knowledge in the delivery of technical projects in these areas.
• Develops client relationships and acts as IPS liaison (point of contact) on project/client sites.
• Affords assistance in recruiting new staff members and promoting IPS to potential hires.
• Makes recommendations to IPS for possible project and procedural improvements.

Qualifications & Requirements

• Bachelor’s degree in Engineering, Project Delivery, or a related discipline, or an equivalent technical degree.
• 7+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• Experience with Risk-Based Approach to Commissioning and Qualification.
• PREFERRED QUALIFICATIONS: General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
• Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes.
• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
• Project Management Professional (PMP) certification or Professional Engineer (PE) license.

Physical Demands

• Must be able to: stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
• Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.

Work Environment

• Can work in both indoor and outdoor environments, which may include exposure to varying working conditions.
• Can adhere to strict cleanroom gowning protocols.

Travel

• This position will have up to 100% travel, or as required by the assigned project.
• Position may be assigned to the client site for an extended period.
• Overnight travel or staying in the city of the Client’s location is possible, depending on the assignment.
• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
• Must have access to reliable transportation.

Safety

• This position is a safety-sensitive position.
• The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.