GMP Operations Specialist

Job description

**Are You Ready?** CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years. Our approach is simple because our Purpose informs everything we do: We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience. **Our Foundational Principles:** - We act with integrity - We serve each other - We serve society - We work for our future At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we’ve challenged ourselves to do what others wouldn’t. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity. For us, operational readiness isn’t simply a goal—it’s a way of life. Tomorrow demands to be at the forefront of today. We get there through tireless effort, precision, efficiency, and an unwavering belief that there is always room for advancement. We’re not interested in how it used to be done. We’re obsessed with how it will be done. ### ### The GMP Operations Specialist is an experienced pharmaceutical manufacturing professional who helps clients improve operational performance, readiness, and execution within GMP-regulated environments. With at least six years of industry experience, this individual evaluates manufacturing operations, organizational readiness, and business processes to identify performance gaps, operational risks, and opportunities for improvement. Working closely with cross-functional teams such as Manufacturing, Quality, Engineering, Supply Chain, and Validation, they develop and implement practical solutions that enhance productivity, compliance, quality, throughput, and overall operational effectiveness. The role focuses on driving measurable improvements through operational assessments, process optimization, training, deviation and CAPA support, risk mitigation, and readiness planning, while leveraging strong analytical, communication, and change management skills to achieve sustainable operational excellence. ### Key Responsibilities: ### · Consult with pharmaceutical clients to assess their current aseptic operations and identify areas for improvement, compliance gaps, and efficiency opportunities. ### · Develop and implement tailored strategies, protocols, and best practices to enhance aseptic operations, including cleanroom design, gowning procedures, aseptic filling processes, and environmental monitoring. ### · Conduct thorough evaluations of client facilities, equipment, and processes to ensure alignment with cGMP regulations and industry standards. ### · Lead and facilitate training sessions and workshops for client personnel on aseptic techniques, cleanroom behavior, and regulatory compliance. ### · Provide guidance and support in conducting media fill studies, air flow pattern studies, interventions, gowning qualification assessments, and environmental monitoring activities. ### · Collaborate closely with client stakeholders, including Quality Assurance, Quality Control, Engineering, and Manufacturing teams, to implement recommended improvements and address compliance issues. ### · Assist clients in the investigation and resolution of aseptic-related deviations, providing expert insights and recommendations for corrective and preventive actions. ### · Stay abreast of emerging industry trends, regulatory updates, and technological advancements in aseptic manufacturing to provide clients with the most up-to-date and effective solutions. ### · Deliver high-quality reports, documentation, and presentations summarizing findings, recommendations, and implementation plans to clients and internal stakeholders. ### · Serve as a trusted advisor and subject matter expert, building strong relationships with clients and fostering long-term partnerships. ### ### Qualifications: Required ### · Bachelor's degree in a scientific discipline or equivalent combination of education and experience. ### · Minimum of 6 years of experience in pharmaceutical manufacturing, with a focus 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, with the ability to assess complex situations and develop practical solutions. ### · Excellent communication, presentation, and interpersonal skills, with the ability to effectively 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. ### · Certification in Aseptic Processing or relevant professional credentials are desirable.