Job Description

Essential Duties and Responsibilities:

• Mentors, coaches, and teaches Manufacturing technicians to perform routine AVI activities for syringes and cartridges as well as support pen packaging and pen assembly activities.
• Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
• Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.
• Actively participate in new equipment and process qualifications.
• Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization by using effective project management, cost control techniques, and Lean Manufacturing.
• Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
• Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.

Minimum Qualifications (Knowledge, Skills, and Abilities)

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's degree with 8+ years demonstrated ability in a cGMP production environment.
• Associate degree and 10 years of cGMP production experience or High School degree with 12 years of experience of cGMP production experience may be considered.
• Experience in automated visual inspection and/or packaging.
• 2+ years of supervisory experience.
• Ability to manage teams to execute activities on the manufacturing floor.
• Experience in a data-driven approach to root cause analysis and prioritization of continuous improvement initiatives (e.g., Six Sigma, 5-why, fishbone diagram).
• Ability to adapt to changing priorities as project demands and business needs change.
• Demonstrated excellence in oral and written communication.

Preferred Qualifications:

• Experience with equipment qualification.
• Lean Manufacturing/Six Sigma Green Belt Certification preferred.
• Experience and greenfield facility start-up experience preferred.
• Ability to explain complex technical issues to external customers/agencies.

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