Job Description:
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 project site near Lexington, Kentucky.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. You will follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
You will also 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-directing and directing the assigned project team, maintaining positive client relationships, etc. You may also manage and perform standalone commissioning services for non-FDA-regulated clients.
Additional Responsibilities
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Directly responsible for the successful delivery of commissioning and compliance projects to IPS’ clients.
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Leads multiple concurrent small, mid-sized, or large projects on behalf of IPS.
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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.
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Coordinates project activities with the IPS Project Lead.
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Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS clients or management on project status and issues.
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Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
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Support, train, mentor, and guide commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.
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Assist or take lead in proposal development, including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.
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Write and manage others in the preparation of C/Q/V documents following established standards and templates, including but not limited to the following:
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C/Q/V Master Plans
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Commissioning Forms
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C/Q/V Protocols and Summary Reports
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Standard Operating Procedures
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Impact Assessments
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Specifications (URS/FRS/DDS)
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FATS/SATs
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Perform and manage others during field/site activities, including, but not limited to, the following:
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Attend and witness FATs and SATs as a representative of IPS clients.
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Execution of commissioning forms and witnessing of vendor start-up and testing.
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Execution of C/Q/V protocols.
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Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
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Perform and manage staff in compiling data packages and preparing reports for completed C/Q/V activities, including ETOPs, protocol data packages, etc.
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Responsible for deviation investigation and resolution of problems and issues encountered during field execution activities.
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Audit project deliverables to assure compliance with established standards.
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Review the work of the assigned project team.
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Ensure the quality of the IPS project work.
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Act as an IPS representative for developing new opportunities and continue to support repeat business.
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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.).
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Provide working knowledge in the delivery of technical projects in these areas.
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Develop client relationships and act as IPS liaison (point of contact) on project/client sites.
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Assist in recruiting new staff members and promoting IPS to potential hires.
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Make recommendations to IPS for possible project and procedural improvements.
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Other duties as assigned.
Qualifications & Requirements:
- Bachelor’s degree in Engineering, Project Delivery, or a related discipline, or an equivalent technical degree.
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7+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
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Experience with Risk-Based Approach to Commissioning and Qualification.
Preferred Qualifications
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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.
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Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes.
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Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
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Project Management Professional (PMP) certification or Professional Engineer (PE) license.
Physical Demands
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Must be able to: stand, sit, and walk for prolonged periods, stoop, kneel, crouch, and crawl as required.
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Must be able to lift and move objects weighing up to 50 pounds and climb ladders as necessary.
Work Environment
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Can work in both indoor and outdoor environments, which may include exposure to varying working conditions.
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Can adhere to strict cleanroom gowning protocols.
Travel
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This position will have up to 50% travel, or as required by the assigned project.
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Position may be assigned to the client site for an extended period.
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Overnight travel or staying in the city of the Client’s location is possible, depending on the assignment.
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Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
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Must have access to reliable transportation.
Safety
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This position is a safety-sensitive position.
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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.
All interviews are conducted either in person or virtually, with video required.
About Us:
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That’s only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
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