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Pharmaceutical Process Specialist (Packaging)

Date: Jul 2, 2019

Location: Wilson, NC, US, 27893

Company: Purdue Pharma L.P. & Affiliates

Working at our Company

Purdue Pharma L.P. develops and provides prescription medicines that meet the evolving needs of healthcare professionals, patients, and caregivers. We were founded by physicians and we are currently led by a physician. Beyond our efforts to provide quality medications, Purdue is committed to supporting national, regional and local collaborations to drive innovations in patient care. Privately held, Purdue is pursuing a pipeline of new medications and technologies through internal research & development and strategic industry partnerships.

Job Summary

The Pharmaceutical Process Specialist, Packaging will efficiently, effectively, and safely clean, set-up, and operate machinery in the manufacturing and/or packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines.

Primary Responsibilities

  • Follow Master Batch Records for the manufacturing and packaging of controlled, oral solid dose (OSD) and other dosage forms when required.
  • Prepare raw materials, blends, and bulk accountability throughout manufacturing processes.
  • Perform weight checks for incoming and dispensed materials ensuring compliance with established procedures. Operates scales including set-up, verification, leveling and challenging. 
  • Identify, report, and resolve quality issues.
  • Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing and/or packaging equipment (oral solid dose manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.).
  • Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.).
  • Cleaning and sanitization of manufacturing and packaging rooms including walls, floors, and ceilings per SOPs.
  • Report accidents and unsafe conditions or unusual circumstances to supervisor.
  • Complete accurate and timely documentation. Follow good documentation practices in accordance with GMP.
  • Handle labeling and components correctly; transferring, counting, FIFO, returns, etc. during packaging processes. 
  • Actively participates in Production team, operational excellence, and other similar projects; and Site communication meetings.
  • Lead process improvement initiatives (i.e PDCA, KAIZEN)
  • Support GMP investigations and proactively identify and eliminate potential root causes.
  • Train, understand, and navigate quality systems (i.e. SAP and Trackwise)
  • Create and revise Standard Operating Procedures (SOPs) in your area of technical mastery.
  • Lead a SME team in determining root cause of GMP events and support the coordination and writing of investigations.
  • Serve as line leader or area supervisor as needed.

Education and Experience

  • High School Diploma or equivalent. 
  • Minimum of ten or more years of pharmaceutical industry experience preferred or equivalent combination of education, demonstrated mechanical skill, and experience in a similar industry such as chemical manufacturing.

Necessary Knowledge, Skills, and Abilities

  • Demonstrated advanced or expert level of knowledge, skills, and abilities in oral solid dose (OSD) pharmaceuticals, and/or others dosage forms.  OSD process area includes:  Packaging and Serialization
  • Demonstrated ability to perform diverse and complex assignments in support of operations.
  • Capability to perform basic/complex mathematical computations of addition, subtraction, multiplication, and division. Understanding of the Metric System of Measurement.
  • Advanced knowledge of the OSD/Bottling, Packaging process area. The work calls for advanced comprehension of the area to solve unusual as well as common work problems, to be able to advise on technical matters, and to serve as a resource on the subject for others in the organization.

Supervisory Responsibilities (if Applicable)

Additional Information

  • Certification/Associate’s/Bachelor’s degree in Manufacturing, Engineering, or Technology related fields
  • Operational Excellence; Six Sigma Green Belt certified
  • Advanced Computerized Manufacturing
  • Controls (Programmable Logic Controls); Motors & Controls; Robotics
  • Maintenance, Installation, and Repair
  • Diagrams/Schematics
  • Root cause analysis/problem solving tools and techniques

Nearest Major Market: Raleigh
Nearest Secondary Market: Rocky Mount

Job Segment: Engineer, Chemical Research, ERP, Pharmaceutical, Engineering, Technology, Quality, Science