What are the responsibilities and job description for the Sr. Validation & Compliance Engineer position at Connexion Systems & Engineering?
Sr. Validation & Compliance Engineer
Indianapolis, IN
Posted: 05/11/2026
Industry: Scientific and Life Sciences
Job Number: 19049
Security Clearance:
Job Description
Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.
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, 1st 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.
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