GMP Operations Specialist

CAI • Kansas City, MO

5d

About The Position

The GMP Operations Specialist is an experienced pharmaceutical manufacturing professional who helps clients improve operational performance, readiness, and execution in GMP-regulated environments. The role evaluates manufacturing operations, organizational readiness, and business processes to identify performance gaps, operational risks, and opportunities for improvement. Working with cross-functional teams, the specialist develops and implements practical solutions to improve productivity, compliance, quality, throughput, and operational effectiveness. The work includes operational assessments, process optimization, training, deviation and CAPA support, risk mitigation, and readiness planning, using analytical, communication, and change management skills to support sustainable operational excellence.

The specialist consults with pharmaceutical clients on aseptic operations, assesses facilities and processes for compliance with cGMP regulations and industry standards, and advises on improvements to cleanroom design, gowning, aseptic filling, and environmental monitoring. The role also involves facilitating training, supporting studies and qualification activities, helping investigate aseptic deviations, and presenting findings and implementation plans to clients and internal stakeholders. The position requires at least six years of pharmaceutical manufacturing experience focused on aseptic operations and includes travel to client sites as needed.

Requirements

• Bachelor’s degree in a scientific discipline, or an equivalent combination of education and experience.
• At least 6 years of pharmaceutical manufacturing experience focused on aseptic operations.
• Proven expertise in aseptic techniques, cleanroom operations, and gowning procedures.
• Comprehensive understanding of cGMP regulations and regulatory requirements for aseptic manufacturing.
• Strong analytical and problem-solving skills, including the ability to assess complex situations and develop practical solutions.
• Excellent communication, presentation, and interpersonal skills, with the ability to engage and influence clients at all levels.
• Ability to manage multiple projects simultaneously, prioritize tasks, and meet deadlines.
• Willingness to travel to client sites as needed.

Nice To Haves

• Certification in Aseptic Processing or relevant professional credentials.

Responsibilities

• Assess clients’ aseptic operations to identify improvement areas, compliance gaps, and efficiency opportunities.
• Develop and implement strategies, protocols, and best practices for aseptic operations, including cleanroom design, gowning procedures, aseptic filling processes, and environmental monitoring.
• Evaluate client facilities, equipment, and processes for alignment with cGMP regulations and industry standards.
• Lead and facilitate training sessions and workshops on aseptic techniques, cleanroom behavior, and regulatory compliance.
• Provide guidance and support for media fill studies, air flow pattern studies, interventions, gowning qualification assessments, and environmental monitoring activities.
• Collaborate with client Quality Assurance, Quality Control, Engineering, and Manufacturing stakeholders to implement improvements and address compliance issues.
• Assist with investigating and resolving aseptic-related deviations and recommend corrective and preventive actions.
• Monitor industry trends, regulatory updates, and technological advancements in aseptic manufacturing.
• Prepare reports, documentation, and presentations summarizing findings, recommendations, and implementation plans for clients and internal stakeholders.
• Serve as a trusted advisor and subject matter expert, building client relationships and long-term partnerships.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior