Senior CQV Project Manager

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 servicescommissioning, qualification, validation, consulting, and related activitiesas defined in project agreements with our clients. You will follow IPS and client standards, industry best practices for C/Q/V services, and regulatory requirements, while acting as the direct client contact for project delivery. Key Activities and Responsibilities Directly responsible for the successful delivery of commissioning and compliance projects to IPS clients, leading multiple concurrent projects. Serve as IPS point of contact to the client for overall project delivery; run meetings, communicate status and issues, and facilitate general project coordination activities. Perform work to meet IPS budget requirements and quality standards; provide timely feedback and reports to clients or management; 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. Assist or lead in proposal developmentincluding scope definition, bid meetings, cost budgets, and presentations. Write and manage the preparation of C/Q/V documents following established standards and templates, such as: 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 staff during field/site activities including FATs and SATs, vendor start?up and testing, execution of protocols, and walk?downs of system drawings (P&IDs, as?built, etc.). Compile data packages and prepare reports for completed C/Q/V activities (ETOPs, protocol data packages, etc.). Investigate deviations and resolve issues encountered during field execution. Audit project deliverables to assure compliance with standards and review work of the assigned team. Represent IPS in developing new opportunities and supporting repeat business. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries. Be self?sufficient and work effectively with limited supervision, leading project teams. Read, understand, and utilize IPS Best Practices and SOPs for compliance services. Demonstrate expertise by industry (Sterile, OSD, BioTech, Medical Device), by equipment/systems, or by validation activity; provide working knowledge in delivering technical projects in these areas. Qualifications & 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.). Preferred Qualifications 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. General exposure and experience in a GMP/Validation discipline with knowledge of pharmaceutical Design/Build/Commission/Validation processes and regulatory requirements in the EU and US FDA. Context, Environment, & Safety This position will have up to 100% travel to the site, or as required by the assigned project. You may be assigned to a client site for an extended period of time. Overnight travel or staying in the city of the clients location is possible depending on the assignment. You will be per the IPS Travel Policy, client?specific travel policy, or project?specific travel plan. You will visit client sites and will be required to adhere to stated safety rules. IPS will not sponsor employment visas for this position 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. Thats 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. #J-18808-Ljbffr