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Validation Engineer
2 months ago
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 be responsible for the lifecycle management of various commissioning, qualification, and/or 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
- 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 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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