Commissioning and Qualification Specialist

3 days ago

Blue Bell, Pennsylvania, United States IPS-Integrated Project Services, LLC Full time
Job Description

This is a general application to the Commissioning, Qualification, and Validation department at IPS-Integrated Project Services, LLC. Please see below for job duties if hired.

Key Responsibilities
  • Perform cGMP compliance-based services, including commissioning, qualification, validation, consulting, and other related activities, as developed and defined in project agreements with clients.
  • Follow IPS and client standards and requirements, as well as good industry practices for C/Q/V services and regulatory requirements.
  • May also perform standalone commissioning services for non-FDA regulated clients.
Key Deliverables
  • Write C/Q/V documents following established standards and templates, including commissioning forms, C/Q/V protocols and summary reports, standard operating procedures, impact assessments, specifications, and FATS/SATs.
  • Perform field/site activities, including attending and witnessing FATs and SATs, executing commissioning forms and witnessing vendor start-up and testing, executing C/Q/V protocols, walkdown and verification of system drawings, compiling data and preparing reports for completed C/Q/V activities, and assisting in deviation investigation and resolution of problems and issues encountered during field execution activities.
Requirements
  • Associates or Bachelor degree in a related field preferred.
  • 2 or more years of relevant 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.
  • 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.
Travel 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 sites 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.

Personal Skills and Traits
  • Proficiency with Microsoft Office applications (Word, Excel, Project, PowerPoint, etc).
  • 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.
Leadership and Teamwork

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 champions 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).

About IPS

IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries.

Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products.

Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industries.

With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East.

Specialties include 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.

All qualified applicants will receive consideration for employment at IPS without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital, or citizenship status, or any other status protected by law.

IPS is proud to be an affirmative action and equal opportunity employer.

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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