Validation Engineer

Job Description
Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at and follow us on LinkedIn:

Our Fortune 500 Pharmaceutical client has an exciting opportunity for a Validation Engineer (Automation).

Job Summary:

We are seeking a Validation Engineer (Automation) with experience in Commissioning and Qualification (C&Q) to support complex manufacturing projects in regulated environments. This role focuses on ensuring equipment and automation systems meet compliance standards and operate effectively within Good Manufacturing Practice (GMP) guidelines.

Responsibilities and Job Requirements:

• Coordinate, develop and maintain validation deliverables per the project requirements

• Gather and write technical data from SMEs, assembly drawings, resource documents, and by observing manufacturing equipment.

• Participate in testing as assigned by the C&Q Lead

• Assist in gathering data for C&Q process metrics as assigned by the C&Q Lead

• Review and approve coordination plans, design, and testing documentation

• Document upload and control of deliverables within Kneat (the client's validation software solution system)

• Uploading and management of C&Q related deliverables within the Project database

• Confirm alignment to internal policies and procedures

Minimum Qualifications:

• Must have 5 years of experience as a Validation Engineer (Automation) in the Pharmaceutical Industry with experience in Commissioning and Qualification (C&Q)

• Proficiency in equipment and automation validation as applied in a GMP regulated area

• Bachelor's degree in Engineering, Biomedical Engineering, or another closely related field in the Life Sciences

• Strong knowledge of external validation standards (e.g., GAMP, ISPE, ICH)

• Strong document management and technical writing skills

• A high proficiency in using Microsoft software such as Word and Excel.

• Experience of working within a schedule driven environment

• Demonstrated experience in creation of deliverables in a GMP regulated environment

Travel Requirements

• Expected ability to travel internationally and domestically to Original Equipment Manufacturers (OEM) for design reviews and Factory Acceptance Testing (FAT) activities (Must be present for the entire FAT process.)

• Expected ability to travel internationally and travel to RS/CM for Site Acceptance Testing (SAT) activities (Must be present for the entire SAT process.)

Other Details:

• Schedule: 40 hours per week

• Contract Role

• Location: Lebanon, Indiana

• Set-up: Hybrid

EEO Employer:

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact .

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

E-Verify Participation:

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at or through their website at dhs.gov/e-verify.