Manufacturing Technical Specialist

Manufacturing Technical Specialist Advance Manufacturing Excellence in a High-Impact Technical Role We are seeking a Manufacturing Technical Specialist to support manufacturing operations by driving process improvements, enhancing compliance, and optimizing operational performance within a regulated production environment. This role plays a critical part in supporting manufacturing readiness, technical transfers, process reliability, quality systems, and continuous improvement initiatives. If you have a strong technical background in manufacturing, aseptic processing, engineering, or life sciences, and enjoy solving complex operational challenges, this opportunity offers meaningful impact and professional growth.

• Technical Transfer & Manufacturing Readiness:
  Support product transfers, new process implementation, and equipment start-up activities. Coordinate manufacturing readiness efforts, including process design, equipment setup, engineering runs, and supporting documentation.
• Review and approve technical documentation related to manufacturing processes, facilities, equipment, validation, maintenance, engineering changes, and document revisions.
• Ensure manufacturing processes are designed, validated, and implemented in compliance with operational and regulatory requirements.
• Process Improvement & Operational Excellence:
  Lead and support continuous improvement initiatives that enhance:
  Process capability;
  Process reliability and robustness;
  Operational efficiency;
  Product quality;
  Compliance performance. Provide technical expertise on manufacturing projects and frontline operational execution. Identify opportunities to improve business processes and drive measurable performance gains.
• Technical Change Management:
  Own and manage technical and operational change activities, including:
  Planned Events; CAPAs (Corrective and Preventive Actions);
  Process and procedure changes;
  Review and approve quality records, training documentation, validation packages, engineering changes, and process improvement documentation. Ensure all technical changes are effectively implemented and maintained in accordance with established quality and regulatory standards.
• Root Cause Analysis & Deviation Management:
  Lead investigations related to manufacturing deviations and non-conformance events. Facilitate Root Cause Analysis (RCA) and structured problem-solving activities. Develop and implement effective remediation plans to prevent recurring issues. Drive sustainable corrective actions that improve operational reliability and compliance.

• Bachelor's degree in Life Sciences, Physical Sciences, Engineering, or a related technical discipline. Equivalent combinations of education and at least two years of relevant industry experience will also be considered.
• Demonstrated ability to troubleshoot complex manufacturing and process-related issues.
• Strong analytical, problem-solving, and decision-making skills.

• Working knowledge of scientific and engineering principles related to aseptic manufacturing processes and equipment.
• Experience with manufacturing technologies such as:
  Isolator systems;
  Filling equipment;
  Inspection systems;
  Packaging equipment;
  Sterilization systems
• Understanding of industry regulations, quality systems, and compliance requirements within regulated manufacturing environments.
• Knowledge of aseptic processing principles, microbiology, sterility assurance, and quality assurance practices associated with biologics or pharmaceutical manufacturing.
• Experience implementing technical changes, including training, documentation updates, process modifications, and regulatory compliance activities.
• Experience leading deviation investigations, root cause analyses, and corrective action programs that successfully reduce repeat events.
• Proven success delivering process improvement initiatives that enhance quality, process capability, operational efficiency, reliability, and regulatory compliance.

This contract opportunity allows you to play a key role in advancing manufacturing performance, supporting critical product and process initiatives, and driving continuous improvement in a highly technical and regulated environment. You''ll collaborate with cross-functional teams while contributing directly to operational excellence and long-term business success.

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