Sr. Validation & Compliance Engineer

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Title:

Sr.

Validation & Compliance Engineer Hiring Organization:

Connexion Systems & Engineering Compensation, Benefits, and Employment Type Duration:

6+ months contract Pay rate: up to $57/hr

Job Location:

Indianapolis, IN (100% onsite)

Schedule:

M-F, 1 st shift Job#: bh19049

Description:

We are seeking experienced Validation & Compliance Engineers to support commissioning, qualification, and validation (CQV) activities within pharmaceutical manufacturing environments. This role is ideal for professionals with strong expertise in equipment and facility qualification, GMP compliance, and cross-functional project execution. Candidates should possess hands-on experience supporting regulated manufacturing operations and be comfortable working in fast-paced, highly collaborative environments. Key Responsibilities Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities Author and review qualification documents, test scripts, deviation reports, and summary reports Perform risk-based commissioning and qualification activities in compliance with FDA, EMA, GMP, and internal quality standards Partner closely with engineering, quality assurance, validation, and manufacturing teams throughout the CQV lifecycle Support technology transfer activities, process validation efforts, and manufacturing handoff Participate in deviation investigations, CAPA implementation, and continuous improvement initiatives Ensure validation documentation is inspection-ready and aligned with regulatory expectations Required Areas of Expertise Commissioning, Qualification & Validation (CQV) Strong hands-on experience developing and executing

IQ/OQ/PQ

protocols for pharmaceutical manufacturing equipment, utilities, and facilities. Pharmaceutical / GMP Regulatory Compliance Deep understanding of FDA, EMA, GMP, and internal quality standards, including deviation investigations, CAPA management, validation documentation, and audit readiness. Cross-Functional Manufacturing Project Execution Proven ability to coordinate with engineering, QA, validation, and operations teams throughout the full CQV lifecycle, including technology transfer and process validation activities. Qualifications 3-10+ years of CQV experience within pharmaceutical manufacturing environments Experience supporting GMP-regulated operations Strong technical writing and documentation skills Familiarity with risk-based validation methodologies Excellent communication and cross-functional collaboration abilities Apply today to support critical pharmaceutical manufacturing and validation initiatives in a highly regulated environment. Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you shortly. You may also send your resume and cover letter via email to the recruiter listed below. You MUST include the Job# and Job Title in your subject line. If you are active in a job search but this job is not for you, please reach out to jobpostings@csetalent.com . We would be glad to help you find the perfect job!