IPS – Integrated Project Services, Inc.

US-PA-Blue Bell
ID
2017-3046
Department
CQV - Validation
# of Openings Remaining
1
Position Type
Regular Full-Time
US-PA-Blue Bell

Position Responsibilities

IPS is hiring! We are actively searching for an experienced CSV Engineer to support our regionally based Computer System Validation team on projects. This position will be based out of our corporate headquarters located in Blue Bell, PA. 

 

This position is slated to last for 6 months but may get extended.  Individuals can be hired on a W2 Temp. or Independent Contractor basis (can hire as regular full time employee for the right candidate).

  

Job Duties and Responsibilities

  • Support eBR (electronic batch records) integration with DeltaV Syncade.
  • Perform field/site activities such as: 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.
  • Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
  • Assists in deviation investigation and resolution for 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.
  • C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
  • Read, understand and utilize the IPS Best Practices and SOPs for delivery of compliance services.
  • Provide consistent, complete and timely feedback and reports to IPS project leaders, project managers or management of project status and issues.
  • 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.
  • 4 or more years of industry 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.
  • 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.
  • Proficiency with Microsoft Office applications.
  • Experience with Cleaning, Process, Computer System, Methods, and other validation activities and processes, beneficial.
  • Experience with Risk-Based Approach to Commissioning and Qualification is beneficial.
  • eBR (electronic batch records) integration experience especially with DeltaV Syncade.

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.

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for updates about what's going on at IPS.