Production & Processes Systems Improvement Specialist

WHAT WE ARE LOOKING FOR

The Production & Processes Systems Improvement Specialist will be operating in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for.

The Production & Processes Systems Improvement Specialist is responsible for driving CAPA plan deployment. This role ensures that all required improvements are implemented in a timely, compliant, and sustainable manner. The Specialist is accountable for elevating manufacturing procedures, batch documentation, process controls, and operator practices to align with FDA requirements and industry best practices for facilities producing terminally sterilized pharmaceutical products. THIS ROLE WILL BE A CONTRACT ROLE OR 18-24 MONTHS AND WILL BE ELIGIBLE FOR GUERBET BENEFITS.

YOUR ROLE

• Lead, coordinate, and independently oversee CAPAs originating from system assessments and remediation plans.
• Ensure CAPAs are implemented on schedule with sustainable corrective and preventive actions.
• Verify CAPA effectiveness through structured follow-up, trending, and objective evidence.
• Track remediation progress and escalate delays or barriers to senior leadership.
• Remediate and redesign manufacturing SOPs, batch records, work instructions, and in-process controls to enhance compliance.
• Implement improvements to line clearance, material flow, equipment status control, and segregation practices across production areas.
• Enhance shop floor documentation accuracy, real-time data entry practices, and logbook governance.
• Ensure manufacturing processes align with regulatory expectations (e.g., FDA guidance for sterilization, environmental control, and cleanroom operations).
• Collaborate with Engineering and Validation to develop or revise process control strategies, equipment parameters, and monitoring requirements.
• Provide on-the-floor support to ensure operator practices, gowning, material handling, and data recording meet GMP standards.
• Partner with Quality to ensure adherence to data integrity, documentation standards, and change control requirements.
• Lead or support investigations into deviations, nonconformances, and process-related issues.
• Performs other duties as assigned by management

YOUR BACKGROUND

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field (or equivalent combination of education and experience).
• 10+ years of experience in pharmaceutical manufacturing operations within GMP-regulated environments.
• Extensive hands-on experience with batch record design, manufacturing controls, and process improvement within GMP facilities.
• Strong understanding of cleanroom operations and environmental control principles, including classifications, airflow, and contamination control.
• Ability to interpret and apply FDA guidance and global regulatory expectations.
• Strong analytical, problem-solving, and root cause analysis skills.
• Proven cross-functional collaboration, influencing, and communication abilities.
• Strong attention to detail with a commitment to data integrity and compliant operations.

Preferred Qualifications

• Experience in aseptic or terminal sterilization manufacturing environments.
• Deep knowledge of terminal sterilization processes, including pressure cascade, HEPA filtration, and environmental monitoring strategies.
• Hands-on experience with aseptic filling operations and airflow visualization (e.g., smoke studies).
• Expertise in cleanroom behaviors, aseptic practices, and intervention minimization.
• Background in microbiology, sterile operations engineering, or process engineering.
• Experience supporting site remediation efforts, regulatory enforcement actions, consent decree environments, or large-scale compliance recovery programs.