Job ID: 1458
Position Summary
We are seeking an experienced Commissioning & Qualification (C&Q) Engineer for a critical contract role in Raritan, NJ. This position is dedicated to supporting pharmaceutical and over-the-counter (OTC) manufacturing operations, ensuring that all equipment and systems are properly commissioned, qualified, and maintained in accordance with regulatory standards. The successful candidate will manage the entire equipment lifecycle, from initial design and procurement through to decommissioning. This role requires a deep understanding of cGMP compliance, validation protocols, and the technical aspects of manufacturing machinery. You will work onsite to provide hands-on engineering support and ensure that production facilities meet the highest levels of safety and quality.
Core Responsibilities
- Lead the commissioning and qualification (C&Q) activities for manufacturing and packaging equipment.
- Manage the equipment lifecycle, including commissioning, qualification, and eventual decommissioning.
- Author and execute comprehensive validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Develop and review User Requirement Specifications (URS), Functional Requirement Specifications (FRS), and Design Specifications.
- Coordinate and oversee Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.
- Ensure all activities are performed in strict accordance with cGMP regulations and internal quality standards.
- Maintain and manage instrument calibration records and ensure all measurement devices are within tolerance.
- Update equipment layouts and revise mechanical, electrical, and utility drawings using AutoCAD or SolidWorks.
- Implement and enforce Lock-Out Tag-Out (LOTO) procedures to ensure personnel safety during maintenance and testing.
- Collaborate with cross-functional teams, including Quality Assurance, Validation, R&D, and Manufacturing, to ensure project alignment.
- Support packaging development for primary, secondary, and tertiary components, including line trial execution and functional testing.
- Troubleshoot equipment failures and packaging issues, providing technical solutions to minimize production downtime.
- Manage project timelines and budgets, ensuring that C&Q activities are completed on schedule.
Required Qualifications
Candidates must have a minimum of 8 years of relevant experience in a pharmaceutical or OTC manufacturing environment. Mandatory experience in equipment commissioning and qualification (C&Q) is required. A strong understanding of cGMP compliance and regulatory documentation is essential. Proficiency in authoring and executing URS, FRS, FAT, and SAT documents is a must. Technical skills should include the ability to update drawings in AutoCAD or SolidWorks and experience with SAP or Bill of Materials (BOM) management. Excellent project management and communication skills are required to effectively coordinate with various departments and stakeholders.
Industry Context and Compliance
In the pharmaceutical industry of 2026, regulatory scrutiny and the need for precision are higher than ever. This role is central to maintaining the validated state of the facility. You will be responsible for ensuring that every piece of equipment operates within its defined parameters and that all documentation is audit-ready. Your expertise will help prevent compliance gaps and ensure the safe production of healthcare products.
Work Environment
This is a contract C2C position requiring full-time onsite presence in Raritan, NJ. You will be part of a professional engineering team dedicated to operational excellence. The role offers the opportunity to work with state-of-the-art manufacturing technology and contribute to the success of a leading pharmaceutical facility. We value engineers who are proactive, detail-oriented, and committed to maintaining the highest standards of quality and safety.
Special Requirements
Contract C2C; Pharma/OTC industry experience mandatory; Onsite requirement in Raritan, NJ.
Compensation & Location
Salary: $135,000 – $185,000 per year (Estimated)
Location: Raritan, NJ
Recruiter / Company – Contact Information
Recruiter / Employer: Scalable Systems
Email: sudhanshu.singh@scalable-systems.com
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