Equipment Validation Engineer

Job#: 2073087

Job Description:

Role: Equipment Validation Engineer

Location: Indianapolis, IN (On-Site)

Type: Long Term Contract

Apex Systems, a global leader in Technology Services, is searching for an Equipment Validation Engineer in Indianapolis, IN for a large Life Sciences client. This is a long term contract with an immediate start date. This role requires on site support 5 days a week due to the nature of the role. See below for more details!

Duties and Responsibilities:

• Supports the implementation, maintenance, and monitoring of processes and procedures to ensure departments are in compliance with relevant guidance and requirements.
• Responsible for retiring devices when applicable, moving devices, and following Qualification processes.
• Strong experience in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in the Validation lifecycle.
• Manage the document and record control and archiving activities.
• Manage the training and competency program.
• Supports the tracking, monitoring, and presentation of operational and quality metrics.
• Initiates or supports quality improvements initiatives to enhance performance and/or mitigate quality or compliance risks, as needed.
• Supports the implementation of corrective actions as a result of audit observations and investigations, as necessary.

Minimum Education and Experience Required:

• Bachelor's degree in Life Sciences or equivalent with 3+ years of related experience within the healthcare industry.
• 2+ years relevant experience in areas of Quality Assurance, Auditing, and/or Validation, in regulated industries-preferably in Pharmaceutical, Biotech, Medical device

Preferred Qualifications:

• Experience in non-conformance events, change control management and risk management.
• Working knowledge of accreditation standards, practice, and guidelines sufficient to guide laboratory operations.
• Knowledge of Google Cloud PlatformLP regulation including knowledge of 21 CFR Part 11.
• Ability to comprehend regulations and guidance documents and technical information related to equipment, processes, and regulatory expectations.
• Strong organization to communicate to multi-disciplinary project teams.
• Familiarity with collecting and reporting Quality Metrics.
• Computer literate and familiar with most common software applications (i.e., Word, Excel etc.)
• Working experience with GMARS, SmartLab, and SmartSheet.
• Capable of working independently with minimal supervision and interacting with staff in a fast-paced sometimes pressure-filled environment.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.