Quality Engineer

Cindavi; United States; On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Annual Bonus

Job summary

A pharmaceutical manufacturing company seeks a Validation Engineer to oversee validation activities in a regulated environment. The ideal candidate will develop and maintain protocols to ensure compliance with regulatory standards. Responsibilities include executing validation protocols and leading risk assessments. A Bachelor's degree in a scientific discipline and 2-5+ years of validation experience are required. The position offers a competitive salary range of $75,000 to $90,000 annually, joining a team focused on bringing therapeutics to market.

Qualifications

• Bachelor’s degree or equivalent relevant experience.
• 2 to 5+ years of validation experience in pharmaceuticals or medical devices.
• Strong understanding of validation principles and regulatory requirements.

Responsibilities

• Develop and maintain validation protocols and reports.
• Lead risk assessments related to validation activities.
• Coordinate validation activities, including IQ, OQ, and PQ.

Skills

Validation principles

Regulatory requirements understanding

cGMP knowledge

Cross-functional team collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

IQ, OQ, PQ documentation

Job description

Base pay range

$75,000.00/yr - $90,000.00/yr

Additional compensation types

• Annual Bonus
• Direct message the job poster from Cindavi

Validation Engineer

Help bring life-changing therapeutics to market by owning validation activities in a regulated, commercial manufacturing environment.

Job Description

We are seeking a Validation Engineer to support validation activities within a commercial manufacturing facility. This role is responsible for developing, executing, and maintaining validation protocols to ensure systems, processes, and products meet regulatory, quality, and internal requirements. The Validation Engineer will work closely with cross‑functional teams to support Therapeutics manufacturing operations and continuous improvement initiatives in a cGMP environment.

Responsibilities

• Develop, execute, and maintain validation protocols and reports aligned with regulatory requirements and project objectives
• Lead and contribute to risk assessments related to validation activities
• Ensure validation work is performed in accordance with internal validation policies, procedures, and the Master Validation Plan
• Coordinate and execute validation activities including IQ, OQ, PQ, requalification, and revalidation of critical systems and utilities
• Assist in preparing protocols for process qualification, cleaning validation, equipment commissioning and qualification, and CSV documentation
• Review and analyze analytical and physical data generated during validation activities
• Author validation and qualification final reports supported by objective evidence and obtain required approvals
• Partner with Development, Manufacturing, Engineering, and Quality teams to generate risk management deliverables such as PHAs, SIAs, FMEs, and risk management reports
• Work closely with R&D, Quality, Engineering, Manufacturing, and IT teams to align validation activities with project milestones

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent relevant experience
• 2 to 5+ years of validation experience within pharmaceutical or medical device manufacturing
• Strong understanding of validation principles, methodologies, and regulatory requirements
• Hands‑on experience drafting and executing IQ, OQ, and PQ documentation
• Experience working in cGMP‑regulated environments

Seniority level

• Associate

Employment type

• Full‑time

Job function

• Engineering, Manufacturing, and Management

Industries

• Manufacturing, Pharmaceutical Manufacturing, and Medical Equipment Manufacturing