Job Description

Job Description

Job Description

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, team member for our NC team.

Job Description:

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

Position Responsibilities/Essential Functions

• • Execute System Lifecycle deliverables from Commissioning and qualification (C&Q) and Computer System Validation (CSV) planning documents through System Retirement.
  • Actively participate among cross-functional teams and support project initiatives to ensure projects are delivered on time and to required quality standards.
  • Support execution of large product launches/releases, small capital projects, and process improvement changes related to the manufacturing and/or laboratory systems within the client site.

Requirements

• • Bachelor’s degree and/or Master’s degree in Engineering or Technical discipline required
  • 1 – 3 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.)
  • 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 25% 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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