What are the responsibilities and job description for the CQV Project Manager position at IPS-Integrated Project Services?
Job Description:
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 also follows IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
Additionally, you will 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 assigned project team, maintaining positive client relationships, etc.
What You'll Do
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 also follows IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements.
Additionally, you will 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 assigned project team, maintaining positive client relationships, etc.
What You'll Do
- Is responsible for the successful delivery of commissioning and compliance projects to IPS clients. Lead multiple concurrent small, mid-sized, or large projects on behalf of IPS.
- IPS point of contact to the client for overall project delivery.
- 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 guide commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.
- Assist or take the lead in proposal development including scope definition, attend 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:
- 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
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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.
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Execution of commissioning forms and witnessing 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 ensure compliance with established standards. Review the work of the assigned project team.
- Assure quality of IPS project work.
- C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
- Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
- Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and takes your career to new heights!
Qualifications & 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 in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities,
- Experience with a Risk-Based Approach to Commissioning and Qualification.
Preferred Qualifications
- Project Management Professional (PMP) certification or a Professional Engineer (PE) license.
- Equipment, Systems, and Software.
- 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.
- Experience with Cleaning, Processes, Computer Systems, Methods, and other validation activities and processes.
Context, Environment, & Safety
- This position will have up to 100% travel, or as required by the assigned project.
- The position may be assigned to the client site for an extended period. Overnight travel or staying in the city of the Client’s location is possible depending on the assignment.
- Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
- The position will visit Client sites and will be required to adhere to stated safety rules.
This position is a safety-sensitive position. 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.
About Us:
IPS, a Berkshire Hathaway company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. IPS, inclusive of its Enterprise entities, has over 3,500 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.
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.
Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
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.
Attention Search Firms / Third-Party Recruiters: IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via email, the Internet, or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.
