CQV Project Manager

IPS-Integrated Project Services•Lexington, KY

About The Position

At IPS, you will apply your knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to pharmaceutical, biotech, and animal health research and manufacturing facilities. We are looking for a dedicated Project Manager of CQV to join our team at our office located in __________. 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.

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.

Nice To Haves

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.

Responsibilities

Directly responsible for the successful delivery of commissioning and compliance projects to IPS’ clients.
Leads 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.
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.
Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
Support, train, mentor, and guide commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.
Assist or take lead in proposal development, including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.
Write and manage 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
Perform and manage others during field/site activities, including, but not limited to, the following: Attend and witness 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.)
Perform and manage staff in compiling data packages and preparing 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.
Audit project deliverables to assure compliance with established standards.
Review the work of the assigned project team.
Ensure the quality of the IPS project work.
Act as an IPS representative for developing new opportunities and continue 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.).
Provide working knowledge in the delivery of technical projects in these areas.
Develop client relationships and act as IPS liaison (point of contact) on project/client sites.
Assist in recruiting new staff members and promoting IPS to potential hires.
Make recommendations to IPS for possible project and procedural improvements.
Other duties as assigned.