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 is a contract role for 18-24 months and will be eligible for Guerbet's benefits, etc

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YOUR ROL

• ELead, coordinate, and independently oversee CAPAs originating from system assessments and remediation plan
• sEnsure CAPAs are implemented on schedule with sustainable corrective and preventive action
• sVerify CAPA effectiveness through structured follow-up, trending, and objective evidenc
• eTrack remediation progress and escalate delays or barriers to senior leadershi
• pRemediate and redesign manufacturing SOPs, batch records, work instructions, and in-process controls to enhance complianc
• eImplement improvements to line clearance, material flow, equipment status control, and segregation practices across production area
• sEnhance shop floor documentation accuracy, real-time data entry practices, and logbook governanc
• eEnsure 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 requirement
• sProvide on-the-floor support to ensure operator practices, gowning, material handling, and data recording meet GMP standard
• sPartner with Quality to ensure adherence to data integrity, documentation standards, and change control requirement
• sLead or support investigations into deviations, nonconformances, and process-related issue
• sPerforms other duties as assigned by managemen

tDepartment Specific/Non-Essential Function

• sSupport process validation activities, including requalification, PPQ, and ongoing process verification effort
• sParticipate in audit readiness activities, regulatory inspections, and internal/external assessment
• sServe as a subject matter expert for production systems during regulatory interactions and response development
• sProvide coaching and training to production personnel on procedures, controls, and best practice
• sContribute to continuous improvement initiatives and broader operational excellence program
• sPerforms other duties as assigned by managemen

tYOUR BACKGRO UN

DRequired Qualification

• sBachelor’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 environment
• sExtensive hands-on experience with batch record design, manufacturing controls, and process improvement within GMP facilitie
• sStrong understanding of cleanroom operations and environmental control principles, including classifications, airflow, and contamination contro
• lAbility to interpret and apply FDA guidance and global regulatory expectation
• sStrong analytical, problem-solving, and root cause analysis skill
• sProven cross-functional collaboration, influencing, and communication abilitie
• sStrong attention to detail with a commitment to data integrity and compliant operation

sPreferred Qualification

• sExperience in aseptic or terminal sterilization manufacturing environment
• sDeep knowledge of terminal sterilization processes, including pressure cascade, HEPA filtration, and environmental monitoring strategie
• sHands-on experience with aseptic filling operations and airflow visualization (e.g., smoke studies
• )Expertise in cleanroom behaviors, aseptic practices, and intervention minimizatio
• nBackground in microbiology, sterile operations engineering, or process engineerin
• gExperience supporting site remediation efforts, regulatory enforcement actions, consent decree environments, or large-scale compliance recovery program