CQV Engineer: Change Control & Deviations

Verista; Indianapolis (IN); Sur place; USD 69 000 - 103 000; Plein temps

Avantages offerts par ce poste

Health Insurance

401(k) Matching

Paid Time Off

Tuition Reimbursement

Commuter Benefits

Life Insurance

Parental Leave

Résumé du poste

Verista is seeking a CQV Engineer to support change control and deviation management within a regulated cGMP environment. The role focuses on maintaining compliance, supporting quality systems, and documenting manufacturing changes across systems and processes.

The ideal candidate has hands-on CQV lifecycle experience, strong technical writing, and cross-functional collaboration skills, with an onsite requirement in Indianapolis, IN.

Qualifications

• Bachelor’s degree in Chemistry, Engineering, Life Sciences, or related field.
• 1–3 years of experience in CQV, Validation, or Quality Engineering in a regulated industry.
• Strong experience with change control systems and cGMP/GDP environments.
• Familiarity with analytical testing and Chemistry is highly preferred.
• Experience supporting validation lifecycle activities (IQ/OQ/PQ) is a plus.
• Strong technical writing and documentation skills.
• Excellent communication and cross-functional collaboration abilities.
• Onsite job requirement in Indianapolis, IN.

Responsabilités

• Author, review, and manage change controls impacting systems, equipment, and processes.
• Perform impact assessments including product quality and regulatory impact.
• Collaborate with Scientists and Quality to ensure timely, compliant change implementation.
• Support execution of change control deliverables and documentation updates.

Connaissances

Change control systems

cGMP environments

GDP environments

Analytical testing familiarity

Technical writing

Formation

Bachelor’s degree in Chemistry, Engineering, Life Sciences

Description du poste

Verista is seeking a CQV Engineer to support change control and deviation management within a regulated cGMP environment. The role focuses on maintaining compliance, supporting quality systems, and documenting manufacturing changes across systems and processes.

The ideal candidate has hands-on CQV lifecycle experience, strong technical writing, and cross-functional collaboration skills, with an onsite requirement in Indianapolis, IN.