Senior CQV Project Manager

Integrated Project Services•Indianapolis, IN

48d•$138,400 - $184,550•Onsite

About The Position

At IPS, we apply our knowledge, skills, and passion to make a difference in the lives of people, solving complex challenges related to life sciences. We are looking for a dedicated Senior CQV Project Manager to join our talented team supporting the Midwest Region. Project Site: Indianapolis, IN (full-time onsite) In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with our clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. Performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS' clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. Interfaces 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 of assigned project team, maintains positive client relationship, etc. May also manage and perform standalone commissioning services for non-FDA regulated clients. Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights! The salary offered for this role is between $138,400- $184,550, but actual salary offered is dependent on experience, skill set, and education.

Requirements

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).

Nice To Haves

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.

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: o C/Q/V Master Plans o Commissioning Forms o C/Q/V Protocols and Summary Reports o Standard Operating Procedures o Impact Assessments o Specifications (URS/FRS/DDS) o FATS/SATs
Perform and manage others during field/site activities including, but not limited to, the following: o Attend and witness FATs and SATs as a representative of IPS clients. o Execution of commissioning forms and witnessing of vendor start-up and testing. o Execution of C/Q/V protocols. o 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