IPS – Integrated Project Services, Inc.

US-PA-Swiftwater
ID
2017-2998
Department
CQV - Validation
# of Openings Remaining
1
Position Type
Regular Full-Time
US-PA-Swiftwater

Position Responsibilities

IPS is hiring! We are looking for a talented Sterilization Validation Engineer Lead to join our industry leading Commissioning, Qualification and Validation (C/Q/V) team at our state-of-the-art corporate headquarters on-site at our client located in Swiftwater, PA.

 

The Sterilization Validation Engineer Lead performs cGMP Compliance based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS’ clients.  They follow IPS and client standards and requirements, overall good industry practices for C/Q/V services and regulatory requirements.

 

Job Duties and Responsibilities

  • Providing technical support for existing in-house moist-heat sterilization and contracted ethylene oxide and radiation sterilization processes to maintain flow of commercial products
  • Interacting with contract sterilizers and test facilities, including resolution of non-conformances
  • Ability to analyze data and effectively implement process changes
  • Conducting periodic re-qualification of existing sterilization processes
  • Partnering with other sterilization team members in Phoenix, Flagstaff (AZ) and Elkton (MD) to support sterilization initiatives and projects
  • Partnering with manufacturing, packaging, quality assurance, regulatory, and other functions/teams to support sterilization activities, including involvement in bioburden and environmental monitoring programs
  • May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
  • Compiles data and prepares reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
  • Assists in deviation investigations and develops resolutions for problems and issues encountered during field execution activities.
  • Coordinates with the Construction Management department or CM for start-up and vendor testing. Witnesses and troubleshoots as required.
  • Performs the C/Q/V of equipment and systems, including CSV and automation within the pharmaceutical, biotech, and medical device industries.
  • Reads, understands and utilizes IPS Best Practices and SOPs for the delivery of compliance services.
  • Provides consistent, complete and timely feedback and reports to IPS Project Leaders, Project Managers or Management about project status and issues.
  • Lead and complete projects with minimal supervision.
  • Special projects as assigned.

Qualifications & Requirements

  • Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is preferred but not required.
  • Minimum of 7 years’ experience with ethylene oxide sterilization and/or moist heat sterilization process validation, qualification, and applicable industry standards
  • Experience writing and executing PFC, FC, IQ, OQ and PQ forms and protocols for GMP Utilities, Equipment, Systems, and Software.
  • 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 EU and US FDA.
  • Experience with gamma irradiation sterilization processes or other sterilization modes 
  • Experience partnering with contracted suppliers
  • Proficiency with Microsoft Office applications.
  • Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.

Company Overview

About Us

 

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.

 

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.

 

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.

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