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IPS-Integrated Project Services · 2 days ago

Senior CQV Project Manager

Indianapolis, IN

Full-time

Onsite

Senior Level, Lead/Staff

$138K/yr - $185K/yr

10+ years exp

IPS-Integrated Project Services is a global leader in technical consulting and engineering services for complex facilities. They are looking for a dedicated Senior CQV Project Manager to lead commissioning and compliance projects, ensuring adherence to cGMP standards while maintaining positive client relationships and delivering quality results.

ArchitectureConstructionConsultingProcurement

No H1B

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 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 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 of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc

Support, train, mentor, and provide guidance to 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, attend 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 prepare 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 work of assigned project team. Assure quality of IPS project work

Act as an IPS representative for developing new opportunities and continue to support repeat business

Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries

Must be self-sufficient and effectively work with limited to no supervision. Must be able to work and lead team in the delivery of projects

Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services

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

Qualification

CGMP complianceCommissioningQualificationProject Management Professional (PMP)Microsoft Office proficiencyRisk-Based ApproachValidation activitiesClient communicationProposal developmentTeam leadershipMentoring

Required

Bachelor's degree in engineering, Project Delivery, or a related discipline or an equivalent technical degree

10+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA

Experience with Risk-Based Approach to Commissioning and Qualification

Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.)

Preferred

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 a Professional Engineer (PE) license

Experience with Cleaning, Process, Computer Systems, Methods, and other validation activities and processes

General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA

Company

IPS-Integrated Project Services

Glassdoor3.8

IPS-Integrated Project Services, LLC, a Berkshire Hathaway company, is a global leader in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities.

Founded in 1989

Blue Bell, Pennsylvania, USA

1001-5000 employees