IPS is seeking a talented and motivated Validation Project Manager to join our growing southern CA delivery team based in Irvine, CA. Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Additional duties and responsibilities include:
• Directly 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 client for overall project delivery. Runs meetings, communicates status and project issues, and facilitates general project coordination activities.
• 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.
• 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
2) Commissioning Forms
3) C/Q/V Protocols and Summary Reports
4) Standard Operating Procedures
5) Impact Assessments
6) Specifications (URS/FRS/DDS)
• 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.
Qualifications & Requirements:
• Bachelor’s degree in Engineering is required
• 5-10+ years applicable experience as a Project Manager
• Experience with Biotech equipment and facilities, CIP/SIP, cleaning validation, and process validation
• Experience in the pharmaceutical / biotech industry is required
• Must be self-sufficient and effectively work with limited to no supervision
• Must be able to work and lead the team in the delivery of projects
We are proud of our organization and our greatest asset - our team of talented professionals. The Knowledge, Skill and Passion of our team is integral to the success of our entire organization. We are committed to having fun, too. Throughout the year we have various activities such as company barbeques, state of the company addresses and themed celebrations. In addition, we make sure we give back to our communities by participating in local charity events such as Habitat for Humanity volunteer days, Toys for Tots and other local sponsorships.
IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For twenty five years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 700 professionals and offices in California, Indiana, Massachusetts, New Jersey, North Carolina, Brazil and three locations in India. Visit our website at www.ipsdb.com .
IPS is an equal opportunity, affirmative action employer (M/F/D/V).
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.
IPS - Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering,...