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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, but is not limited to, changes required because of 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 and/or Master’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

Travel: Up to 20% of the time to various suppliers, collaborators, and client sites outside of Indianapolis

Compensation:

Competitive Salary and Benefits Package, which includes:

+ Paid Time Off (PTO) for vacation, sick, and company holidays

+ PTO is earned on an accrual basis throughout the calendar year.

+ Health Insurance

+ PACIV pays 90% of the premium for the health insurance plan. Monthly contributions made by PACIV and are distributed through an HSA (Health Savings Account)

+ $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the team member’s cost.

+ 401(k) Retirement Plan with company match

+ Project Performance Bonuses (for qualified projects and employees)

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