Supervisor, Production Pharma/Medical Devices
Artivion, Inc. - Austin, TX
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Job Overview: We are seeking a highly skilled and experienced Supervisor to lead our production team within a pharmaceutical or medical device manufacturing environment. This individual will play a critical role in ensuring that all production activities meet regulatory standards, particularly with the Code of Federal Regulations (CFR) and cleanroom protocols. The ideal candidate will have at least 5 years of supervisory experience in the pharma or medical device industries and a deep understanding of compliance, quality, and safety in a regulated environment. Key Responsibilities: * Lead Production Operations: Oversee daily production activities, ensuring optimal efficiency, quality, and compliance with regulatory requirements. * Regulatory Compliance: Ensure strict adherence to CFR regulations, Good Manufacturing Practices (GMP), and cleanroom standards. Conduct internal audits and collaborate with regulatory teams to address findings. * Team Leadership: Supervise and mentor production staff, managing performance, training, and development. Foster a culture of continuous improvement, quality, and safety within the team. * Cross-functional Collaboration: Work closely with Quality Assurance, Manufacturing Engineering, and Supply Chain teams to resolve production challenges and implement process improvements. * Continuous Improvement: Drive process optimization initiatives to improve operational efficiency and product quality, while reducing costs and enhancing employee engagement. * Safety & Compliance: Lead safety initiatives, ensuring all operations comply with internal and external safety standards. Investigate and resolve quality and processing issues promptly. * Data-Driven Management: Analyze production data to identify trends, make informed decisions, and implement corrective actions where needed. Track key performance indicators (KPIs) to ensure production targets are met. Qualifications: * Experience: Minimum of 5 years of supervisory experience in pharmaceutical or medical device manufacturing environments, HIGHLY preferred * Education: Bachelor's degree in Engineering, Life Sciences, or a related field (preferred) or equivalent work experience. * Regulatory Expertise: In-depth knowledge of CFR regulations, GMP, ISO standards, and cleanroom protocols. * Leadership Skills: Proven ability to lead and manage production teams, with excellent communication, organizational, and problem-solving abilities. * Technical Proficiency: Strong proficiency in MS Office, with experience in using ERP or MES systems to track production data and metrics. Preferred Skills: * Six Sigma or Lean Manufacturing certification is a plus. * Experience with audits and regulatory inspections, both internal and external. * Strong interpersonal skills with the ability to drive engagement and develop talent. This is an excellent opportunity for a seasoned professional with deep pharma/medical device industry experience to take on a leadership role and make a significant impact on our production operations. BENEFITS: * Medical, dental, and vision insurance * 401(k) plan * Unlimited Paid Time Off (PTO) * Employee Stock Purchase Plan Equal Employment Opportunity (EEO) Statement: We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, or any other characteristic protected by law.
Created: 2024-10-09