IPS is hiring! We are looking for a talented CQV Project Manager with Facility and Process Equipment Validation focus to join our industry leading commissioning, qualification and validation team at our Irvine, CA office to support our life science clients in the greater Los Angeles/Thousand Oaks, CA area. This position has an immediate start.
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. Follow IPS and client standards and requirements, overall good industry practices for CQV 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.
Job Duties & Responsibilities
- Directly responsible for the successful delivery of commissioning and compliance projects, including facility and process equipment validation, 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 CQV 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/or manage others in the preparation of CQV documents following established standards and templates, including but not limited to the following:
- CQV Master Plans
- Commissioning Forms
- CQV Protocols and Summary Reports
- Standard Operating Procedures
- Impact Assessments
- 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 CQV 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 CQV 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 CQV 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), by equipment/systems (lyophilizers, 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 areas.
Develop client relationships and act as IPS liaison (point of contact) on project/client sites. Maintain professional contacts and seek new project opportunities for IPS.
Maintain professional conduct and deliver services in a professional and acceptable fashion.
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 CQV methodologies. Make presentations as part of professional organization events.
Special projects as assigned.
Qualifications & Requirements
Bachelor of Science in engineering is required for an engineer; Bachelor of Science in a related field is required for a validation specialist. Non-BS degrees will be evaluated on a case by case basis.
Minimum of five (5) years of experience in pharmaceutical, biotech, commissioning, or validation. Experience in writing and execution of PFC, FC, IQ, OQ and PQ forms and protocols for CGMP utilities, equipment, systems and software.
Experience with cleaning, process, computer system, methods and other validation activities and processes is preferred.
General exposure and experience in a CGMP/Validation discipline with a knowledge and understanding of pharmaceutical design/build/commission/validate processes and how they relate to regulatory requirements and CGMP regulations within the U.S. FDA.
Experience with risk-based approach to commissioning and qualification.
Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint).
Demonstrated experience in utilization of project management principles; PMP certification a plus.
Personal skills and traits include:
- Sense of urgency
- Team player
- Able to multi-task
- Effective time management
- Able to effectively prioritize
- Good interpersonal skills
- Attention to detail
- Excellent customer service skills
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 over twenty 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 1,000 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.
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.
IPS is an equal opportunity, affirmative action employer of protected veterans (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.