Location: 5 days onsite - 950 North Daniels Way, Bloomington, IN 47404
Duration: Permanent, direct hire
Why Open: Team Expansion
Shift/Hours: M-F 7:30-4:30 PM EST (Flexible)
Salary Range / Bill Rate: $96,000-110,000 + 10% yearly bonus
Interview Process: 2 rounds - one 30-minute Teams interview, then final onsite panel interview
MUST HAVES:
5 years of manufacturing validation experience, process, and equipment validation
Experience in a medical device manufacturing environment
Bachelors in Engineering
PLUSSES:
Experience validating semi-automated processes
Experience with IQ, OQ, and PQ
Experience in CQV
About the Role:
Insight Global is looking for a Sr. Validation Engineer to support one of our largest medical device manufacturing clients in Southern Indiana. This person will be an integral part of process validation on the floor daily. This person would ideally come from a medical device manufacturing background and over 5 years of validation experience.
Responsible for performing and documenting validations of medical device component manufacturing processes. This position requires project management and leadership skills to help coordinate efforts between multiple teams. The validation engineer's work will support process risk management, sustaining/continuous improvement efforts, manufacturing changes, and process and product development. More true process validation than equipment validation - the whole series of machines vs just one machine running smoothly and effectively and safely together.
Responsibilities
Validate medical device component manufacturing processes as assigned.
Identify installation qualification requirements, including equipment/ tooling, calibration, documentation, and training requirements.
Characterize processes and their key process parameters for operational qualifications.
Identify the key process outputs and acceptance criteria for performance qualifications.
Arrange and document verification testing.
Support and perform Test Method Validation.
Write excellent validation reports that meet regulatory/company standards.