CQV Engineer​/Validation Engineer

Responsibilities

• Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
• Running test scripts and documenting results.
• Adherence with project schedule for all assigned activities.
• Maintaining clear, detailed records qualification and validation.
• Documenting impact and risk assessments as part of a team.
• Completing user interface testing, software verification, and complete alarm testing on automated systems.
• Developing, reviewing, and executing testing documentation.
• Making recommendations for design or process modification based on test results when executing test scripts.
• General understanding of capital equipment implementation and process knowledge.
• Understanding validation documents, URS, IQ, OQ, PQ

Requirements:

• Must be willing to work onsite in Bloomington, IN.
• Bachelor's Degree or equivalent required.
• 3+ years' experience in leading CQV activities specific to Process Equipment.
• Fill/Finish experience preferred.
• Experience with Track wise/QMS software.
• Proficiency using PC and Microsoft Office tools.
• Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
• Ability to work as part of a team and independently.
• Strong problem-solving and critical thinking skills.
• Excellent organizational and time management skills.
• Strong attention to detail.
• GMP and Good Documentation Practice.
• Capable of working on assigned tasks without mentorship.

We are an equal opportunities employer and welcome applications from all qualified candidates.