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

　　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 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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