Incumbent will be responsible for all aspects in solid dosage packaging of product to ensure compliance with cGMPs, SOPS, FDA, and DEA guidelines.
Primary responsibilities include, but not limited to:
• Set-up, tear down, troubleshoot, and maintain packaging process equipment with little to no supervision or oversight from Maintenance.
• Function as Lead Technician on the line with a strong understanding of operating all equipment and help lead packaging teams to achieve Overall Equipment Effectiveness (OEE).
• Provide strong support for Packaging OEE culture shift. Help maintain, analyze, interpret, and communicate OEE data to drive positive improvements in Packaging efficiencies.
• Maintain strong presence on the floor to ensure that equipment problems are resolved in a timely manner with little downtime.
• Provide feedback or suggestions for improvements to new or existing procedures, processes, or equipment necessary to ensure changeovers are performed efficiently and the process runs with little interruption.
• Inspect and maintain critical parts to ensure that the packaging equipment is operational at all times. Monitor and request new supplies, change parts, and/or spare parts as needed. Maintain spare inventory of critical parts.
• Participate in cross functional teams as necessary to identify the root cause for any equipment or product related deviations. Recommend and implement the necessary preventative or corrective action. Conduct CAPA effectiveness evaluations.
• Act as temporary Technical Process Coordinator (packaging line lead) as needed. Have understanding of procedure and systems used for ordering materials, executing batch records, and closing out packaging orders.
Other Key Functions or Tasks:
• Maintain packaging lines as a line mechanic capacity; may operate lines as necessary.
• Work in compliance with all FDA, DEA, and EHS regulations.
• Calibrate/challenge system components.
• Maintain control systems and equipment.
• Assist Technical Process Coordinator with assuring that the OEE system is properly maintained (process order entry, maintenance notes, etc.).
• Restart OEE Human Machine Interface (HMI) and/or display monitor if needed.
• Partner with Industrial Engineering to identify and drive process improvements.
• Solve system/equipment problems by using manuals and other drawings as needed.
• Assist in the installation, modification, commissioning, and qualification/validation of equipment.
• Use computerized maintenance system to create and execute work orders.
Educational Requirements
• HS graduate with 15+ years cGMP pharmaceutical operations experience or,
• Relevant Associates degree with 10+ years cGMP pharmaceutical operations experience or,
• Relevant Bachelor degree with 7+ years cGMP pharmaceutical operations experience.
• Demonstrate superior technical and mechanical experience/knowledge with pharmaceutical systems and process equipment.
Education/Training/Certifications Requirements: Education/Training/Certifications focus on the following competencies:
• Mechanical • Electrical • Industrial Electronics • Advanced Computerized Manufacturing • Controls (Programmable Logic Controls) • Maintenance, Installation and Repair • Diagrams/Schematics • Motors & Controls • Robotics • Root cause analysis/problem solving tools and techniques
Relevant Degrees may include, but not limited to:
• Electrical/Electronics Technology • Industrial Systems Technology • Manufacturing Technology • PLC/Computer Technology
Required Experience & Technical Requirements
Preferred knowledge of Allen-Bradley Control Systems, Systech Vision System, Systech 2D Serialization System, and/or high-speed automated packaging equipment.
Brief Description/Overview:
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.