IPS – Integrated Project Services, Inc.

Job Locations US-CA-Irvine | US-CA-Thousand Oaks
ID
2018-3133
Department
CQV - Validation
# of Openings Remaining
1
Position Type
Regular Full-Time
Location : Location
US-CA-Irvine

Position Responsibilities

IPS is hiring! We are looking for an experienced Senior Validation Engineer to join our industry leading Commissioning, Qualification and Validation (CQV) team based out of our Irvine, CA office. This postion will focus on Thousand Oaks based regional projects. Candidates must be local to the Thousand Oaks, CA area (T&L is not available) and has an immediate start date.

 

The Senior Validation Engineer 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

  • Writes C/Q/V documents following established standards and templates.
  • Performs field/site activities such as: attending and witnessing FATs and SATs as a representative of IPS clients, executes commissioning forms and witnesses vendor start-up and testing, executes C/Q/V protocols, walkdowns and performs verification of system drawings.
  • 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.
  • May coordinate with the construction management department 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 medical device industry.
  • 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.
  • 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.
  • More than 7 (seven) years of experience doing validation, commissioning and/or QA work within the life science industry.
  • Experience writing and executing PFC, FC, IQ, OQ and PQ forms and protocols for CGMP 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 and methods. Other validation activities and processes are considered beneficial.
  • Experience with risk-based approach to commissioning and qualification is beneficial.
  • 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

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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