Validation Engineer II

IPS-Integrated Project Services; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

IPS-Integrated Project Services seeks a Validation Engineer II to support cGMP compliance in the pharmaceutical sector. The role involves writing C/Q/V documents, performing commissioning services, and ensuring adherence to industry standards. This entry-level position offers opportunities for travel and professional growth within a leading global firm.

Qualifications

• 2+ years of relevant work experience.
• Entry-level position in Pharmaceutical, Biotech, or Medical Device.
• Experience in writing and execution of C/Q/V protocols preferred.

Responsibilities

• Perform cGMP compliance-based services including commissioning, qualification, and validation.
• Write C/Q/V documents and perform field/site activities.
• Assist in deviation investigation and resolution during field execution.

Skills

cGMP compliance

Commissioning

Validation

Consulting

Problem-solving

Education

Bachelor of Science in Engineering

Job description

Join to apply for the Validation Engineer II role at IPS-Integrated Project Services.

Get AI-powered advice on this job and more exclusive features.

Job Description

At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in _____________.

In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.

Additional Responsibilities

• Write C/Q/V documents following established standards and templates, including but not limited to:
• Commissioning Forms
• C/Q/V Protocols and Summary Reports
• Standard Operating Procedures
• Impact Assessments
• Specifications (URS/FRS/DDS)
• FATS/SATs
• Perform field/site activities including, but not limited to:
• 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.)
• Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
• Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
• Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
• Primary responsibilities include 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 the delivery of compliance services.
• Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.

Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons!

Qualifications & Requirements

• Bachelor of Science in Engineering.
• 2+ years of relevant work experience.
• This is an entry-level position.
• Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.

Preferred Qualifications

• Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/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/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.

Context & Safety

• This position will have up to 100% travel to the site, or as required by the assigned project.
• You may be assigned to a client site for an extended period.
• Overnight travel or staying in the city of the client’s location is possible depending on the assignment.
• Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
• You 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.

About Us

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. IPS, inclusive of its Enterprise entities, has over 3,500 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.

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. Resumes submitted without a valid written search agreement will be deemed the property of IPS, and no fee will be paid if a candidate is hired as a result.