- Run meetings, communicate status and project issues, frequently check in with client representative(s), and facilitate general project coordination activities.
- Coordinates project activities with the Project Lead.
- Perform work to meet budget requirements and quality standards.
- Provide consistent, complete, and timely feedback and reports to 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 the 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.
- Responsible for deviation investigation and resolution of problems and issues encountered during field execution activities.
- Audit project deliverables to ensure compliance with established standards.
- Provide working knowledge in the delivery of technical projects in these areas.
- Develop client relationships and act as IPS liaison 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.
- Stay current (training, reading, professional organization involvement) with industry trends and current C/Q/V methodologies.
- Bachelors 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.).
- 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.
- 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.
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CQV, Senior Project Manager - Cary, United States - IPS-Integrated Project Services, LLC
Description
Job Description:
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.
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.
Additionally, you will interface directly with our 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 teams, and maintaining positive client relationships.
What You'll Do
Come join a caring, nimble team that delivers world-class designs for our pharmaceutical clients and take your career to new heights
Qualifications & Requirements:Preferred Qualifications
Context, Environment, & Safety
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. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.
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.
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