Compliance Engineer | Pharmaceutical | C&Q

Job Description

Job Description

Location: On Site
Industry: Pharmaceutical Manufacturing – Solid Dosage
Position Type: Contract

We are seeking a motivated and detail-oriented Compliance Engineer to support projects and operations within a GMP-regulated pharmaceutical manufacturing environment. This role will focus on ensuring compliance, supporting C&Q-related activities, and partnering with cross-functional teams to maintain quality standards and operational excellence.

The ideal candidate will bring experience in pharmaceutical manufacturing environments and enjoy working in collaborative, fast-paced settings that support engineering and manufacturing initiatives.

This is a contract-based opportunity with an initial duration of one (1) year and the potential for extension up to three (3) years depending on project needs, performance, and business priorities.

Main Responsibilities

• Support compliance activities related to pharmaceutical engineering and C&Q projects.
• Partner with Project Execution and Engineering teams to support investigations and follow-up activities when needed.
• Assist with CAPA-related actions and support timely completion of quality initiatives.
• Monitor compliance-related metrics and help track completion of key quality activities.
• Review and support GMP documentation to ensure quality and compliance standards are met.
• Participate in change control, documentation review, and quality system activities.
• Support onboarding activities and coordinate documentation for new team members.
• Collaborate with Quality, Manufacturing, Engineering, and Validation teams.
• Support audit readiness and inspection preparation efforts.
• Assist with continuous improvement initiatives and process enhancement activities.
• Maintain accurate documentation and ensure compliance with internal procedures.

General Requirements

• Knowledge of GMP regulations and pharmaceutical compliance practices.
• Familiarity with Commissioning & Qualification (C&Q) processes and validation activities.
• Understanding of quality systems, documentation practices, CAPA, and change management.
• Strong organizational and communication skills.
• Ability to work independently and within cross-functional teams.
• Strong attention to detail and problem-solving mindset.
• Proficiency with Microsoft Office and electronic documentation systems.
• Experience with documentation platforms such as Kneat or similar systems is a plus.

Education

• Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, Biomedical, Electrical, or related field)
• Life Sciences or related technical discipline
• Equivalent experience in pharmaceutical environments may be considered.

Experience

• Minimum 3+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
• Experience supporting compliance, quality, engineering, validation, or C&Q-related activities.
• Previous experience in pharmaceutical manufacturing environments required.
• Experience in Solid Dosage manufacturing is preferred.
• Experience with GMP documentation, CAPA, investigations, and quality systems is a plus.
• Experience supporting manufacturing operations and cross-functional project teams preferred.

Physical Requirements

• Ability to work in office and manufacturing environments.
• Ability to walk production areas and support field activities.
• May require prolonged periods sitting, standing, and computer use.
• Ability to occasionally lift up to 25 lbs.
• Ability to wear required PPE and cleanroom attire as needed.