IPS is hiring! We are looking for a talented Commissioning, Qualification & Validation Project Manager to join our industry leading Validation/Compliance team out of our Morrisville, NC office.
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
- Directly responsible for the successful delivery of commissioning and compliance projects 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 C/Q/V 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 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)
- 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.
- 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. 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, Medical Device), by equipment/systems (lyos, 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 C/Q/V methodologies. Make presentations as part of professional organization events.
- Other duties as assigned.
Qualifications & Requirements
REQUIRED EDUCATION/QUALIFICATIONS /WORK EXPERIENCE
- Bachelor's degree in Engineering, Project Delivery or a related discipline or an equivalent technical degree.
- Project Management Professional (PMP) certification or Professional Engineer (PE) license desirable.
- A minimum of 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, Equipment, Systems, and Software a plus.
- Experience with Risk-Based Approach to Commissioning and Qualification.
- General exposure and experience in a GMP/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 E.U. and U.S. FDA helpful.
- Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes is 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
- Team player
- 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 1,100 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, 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).
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.