Validation Engineer

PACIV; Indianapolis (IN); On-site; USD 70,000 - 130,000; Full time

Job summary

PACIV, a leading engineering firm, is seeking a full-time Validation Engineer for their Indianapolis office. The role involves managing various facets of commissioning and qualification within Bio-Pharmaceutical sites, contributing to large capital projects. The ideal candidate will possess a bachelor's degree in engineering, along with 2+ years of validation experience and strong communication skills, working in a dynamic, high-pressure environment.

Benefits

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

Qualifications

• 2+ years of validation experience in the Pharmaceutical Industry.
• Comfortable in a 24/7 manufacturing environment.
• Ability to handle high-pressure, high-stress work.

Responsibilities

• Develop and drive project validation plans and risk assessments.
• Understand commissioning and qualification processes.
• Lead project review meetings and change management assessments.

Skills

Strong interpersonal skills

Communication

Organizational skills

Computer literacy

Education

Bachelor’s degree in engineering or a technical discipline

Tools

MS Word

MS Project

MS Excel

Job description

Direct message the job poster from PACIV

PACIV, an international control systems integration and regulatory compliance engineering firm servicing Bio-Pharmaceutical, Medical Device, F&B, and Water/Wastewater clients, is looking for a full-time Validation Engineer (Level I) team member for our USA office (Indianapolis).

Job Description:

The Validation Engineer will manage various commissioning, qualification, and/or validation facets within our client’s Biotechnology and Pharmaceutical sites. This support service will work within the client’s validation, project management, quality, and/or automation department team(s).

Position Responsibilities/Essential Functions

• Develop and/or drive to completion the following Commissioning and Qualification (C&Q) deliverables: project validation plan, risk assessments and project strategies, requirements, functional design specifications, software/hardware design specifications, impact assessments, trace matrix, test cases/scripts, engineering studies, and summary reports.
• Thoroughly understand the commissioning and qualification process and influence cross-functional team members to ensure adherence to governing policy and procedure.
• Ensure change management is properly assessed throughout the course of the project and all documentation impacted is maintained. This includes changes due to evolving design and failures during test execution.
• Lead and participate in project review meetings such as design reviews, alignment sessions, test strategy, test execution reviews, project status, and qualification review meetings.
• Manage and report project scope and budget considerations as it relate to C&Q.
• Develop and maintain documentation within an electronic lifecycle management system capable of paperless execution.
• Support the execution of large capital projects that contribute to the expansion of pharmaceutical manufacturing. Projects may include the following types of equipment: active pharmaceutical ingredient manufacturing, filling operations, delivery device assembly, packaging, facilities and utilities, and automation.

Requirements

• Bachelor’s degree in engineering or a technical discipline required
• 2+ years of validation experience in the Pharmaceutical Industry
• Comfortable with a 24/7 manufacturing environment
• Works well with others within a team and takes accountability
• Can handle a high-pressure, high-stress work environment
• Result-driven and self-motivated
• Strong interpersonal and communication skills (verbal and presentation)
• Organized with strong computer literacy, such as MS Word, Project, Excel, etc.

Desired Hard Skill Sets (via Internships/Co-Ops):

• Familiarity with Validation principles and executable deliverables (i.e. Requirements, Design, Testing, Reports, etc.)
• C&Q and/or CSV experience, ideally around Data Integrity and CFR Part 11 Electronic Records and Signatures
• Project Management experience with the ability to lead and drive projects to completion autonomously

Other Requirements

Location: Indianapolis

Travel: Up to 40% of the time to various suppliers, collaborators, and client sites outside of Indianapolis

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

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