Incumbent will be responsible for the operation, troubleshooting, and repair of solid dosage packaging equipment.
The ideal candidate will take ownership of packaging equipment, diagnose and troubleshoot problems while working in a collaborative team environment. Incumbent will take responsibility of first level preventative maintenance work and troubleshooting to ensuring reliability of equipment operation.
1. Operates production equipment required to package solid dose pharmaceutical controlled substance products in compliance with cGMPs, SOPs, FDA and DEA guidelines.
2. Responsible for all packaging support functions such as preparation of equipment and packaging components to be used in support of/or packaging of the product.
3. Completes accurate and timely documentation to comply with FDA and GCP/GLP/GMP regulations.
4. Uses computer systems to enter batch data, review Standards Operating Procedures (SOPs), and operate computerized packaging equipment. 5. Maintains current training in packaging process areas in order to support operational requirements. As required, develop the skills needed to perform duties in other areas to support schedule fluctuations.
6. Adheres to all regulatory guidelines including execution of supporting product documentation.
7. Adheres to all safety practices and participates in safety orientations. Works regularly with the Safety Team Leader and/or Committee to increase safety awareness in the department.
8. Provides technical input on related production processes.
9. Provides technical guidance and training to Process Technician I and Process Technician II colleagues.
10. Participates in investigations including root cause analysis and CAPA plans.
11. Identifies initiatives to minimize compliance risks.
12. Uses knowledge of pharmaceutical processes and associated production equipment to solve production and process problems.
13. Communicates with Technical Process Coordinator, Supervisor, and/or Senior Supervisor to ensure current requirements are met.
14. Performs other related assignments and duties as required and assigned.
1. Participates in Production team and Site communication meetings. Takes a leading role in supporting special departmental projects.
2. Demonstrates and fosters teamwork, positive can-do attitude and initiative. Respects the contributions of others. Demonstrates respect for diversity.
3. Collaborates constructively with internal and external customers. Fosters and implements forums where team building skills are utilized.
Educational Requirements v HS graduate with 10+ years cGMP pharmaceutical operations experience, solid dosage packaging equipment. Understanding of basic computer skills. -or-
v Associates degree with 7+ years cGMP pharmaceutical operations experience, solid dosage packaging equipment. Strong computer skills. -or-
v Bachelors Degree with 5+ years cGMP pharmaceutical operations experience, solid dosage packaging equipment. Strong computer skills. Required Experience & Technical Requirements 5-10 years cGMP pharmaceutical operations experience in a solid dose packaging environment.
In addition, have strong, demonstrated mechanical and problem solving/troubleshooting skills. Ideal candidate will have an understanding of basic PLCs controls and troubleshooting.
Ms. Angela Kearney Recruiter
Purdue Pharma - 2 years ago
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