IPS – Integrated Project Services, Inc. Sr. CQV Lead / Department Manager in Irvine, California
IPS is Hiring! We are looking for a talented Sr. CQV Lead / Department Manager to join our industry leading CQV/Validation Team at our growing Orange County office located in Irvine, California.
In this role, the Sr. CQV Lead / Department Lead performs cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients. Follows IPS and client standards and requirements, overall good industry practices for C/Q/V 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.
KEY ACTIVITIES AND RESPONSIBILITIES
Assist an assigned Project Manager or is directly responsible for the successful delivery of compliance projects to IPS’ clients. Leads independent (sole individual), small, or mid-sized projects on behalf of IPS.
IPS point of contact to client for day-to-day project delivery. Runs meetings, communicates status and project issues, frequently “checks-in” with client representative(s), 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 project managers or management of project status and issues. Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
Support, train, and provide guidance to validation specialists/engineers in the delivery of C/Q/V services for assigned projects.
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
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
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.
Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
Coordinate with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Audit project deliverables to assure compliance with established standards. Review work of assigned project team.
Assist in proposal development including scope definition, attend bid meetings, development of hours and cost budgets, proposal presentations, etc.
Act as an IPS representative for developing new opportunities and continue to support repeat business.
Primary responsibilities include C/Q/V 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.
Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services.
Other duties as assigned.
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REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE
Bachelor’s degree in Engineering, or a related discipline or an equivalent technical degree,
A minimum of 5 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 and protocols for GMP Utilities, Equipment, Systems, and Software.
Experience with Cleaning, Process, Computer System, Methods and other validation activities and processes.
Detailed experience in the discipline of GMP/Validation with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validate processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA and international Standards and guidance (ASTM, ICH, ISPE, etc.).
Experience with Risk-Based Approach to Commissioning and Qualification, beneficial.
CONTEXT AND ENVIRONMENT AND SAFETY
This position will have up to 100% travel, or as required by the assigned project. Position may be assigned to client site for an extended period of time. Overnight travel or staying in the city of Client’s location is possible depending on assignment. Travel will be per the IPS Travel Policy, client specific travel policy or project specific travel plan. Position will visit Client sites and will be required to adhere to stated safety rules. Position may visit active construction sights and will be required to take site safety training and adhere to site 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.
Proficiency with Microsoft Office applications (Word, Excel, Project, Powerpoint, etc).
Personal skills and traits include:
Sense of urgency
Able to multi-task
Effective time management
Able to effectively prioritize
Good interpersonal skills
Attention to detail
Excellent customer service skills
Leads by example. Deems the respect of upper management, peers and subordinates. Empowers staff to succeed.
Supports and deploys technical training programs that assure competency and advancement levels to support corporate goals.
Promotes a friendly and efficient work environment, which rewards achievement and recognizes teamwork and champion’s technical advancement, which supports our corporate goals.
Maintain professional conduct and deliver services in a professional and acceptable fashion.
- Works in conjunction with department management in recruiting new staff members and promoting IPS to potential hires (focused on cleaning and process validation).
Core Value Candidate Qualifications
- Must exhibit an entrepreneurial spirit by consistently seeking new opportunities to add value to the organization. Must strive for excellence in all aspects of job performance.
Must approach their work enthusiastically with a contagious energy and drive that shows everyone they love what they do.
Must display creativity and innovation by continually working to improve solutions, tools, methods and service delivery system.
Must conduct oneself with an uncompromising commitment to the welfare of our clients and each other. Must act in an ethical, professional and respectful manner at all times.
Must exhibit the ability to build and sustain long term relationships of mutual value through teamwork.
Must be driven to succeed and committed to goal attainment.
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 thirty 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 1,400 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Germany, Ireland, 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). IPS will consider qualified applicants with criminal histories.
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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