Pharmaceutical Process Specialist, Packaging, 1st shift (M-Th: 6:00am - 4:30pm)
Purdue Pharma L.P. and its subsidiaries develop, manufacture and market medications and consumer health products to 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 through internal research & development and strategic industry partnerships.
For close to two decades Purdue has engaged in many initiatives to stem prescription opioid abuse. We are committed to bringing lifesaving relief to communities and individuals suffering from substance use disorder and overdose. We are currently developing or supporting the development of two essential life-saving opioid overdose reversal medications and have the capability to manufacture others for medication assisted treatment. Providing these medicines has the potential to improve and save countless lives.
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
We are building an exciting path forward, and we are committed to recruiting a dedicated team of professionals who advance our expertise through a commitment to Purdue’s Values: Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other.
At Purdue Pharma and our subsidiaries, you have a unique career opportunity to work differently, uncover and seize new opportunities, and take a hands-on, ownership approach to your work. We go beyond traditional roles and find creative ways to extend our skills and interests, challenging ourselves to contribute in different, meaningful ways. We strive to create an environment where you can bring your best to work each day. We welcome the opportunity to have you on our team!
The Pharmaceutical Process Specialist will efficiently, effectively, and safely clean, set-up, and operate machinery in the packaging area while adhering to applicable cGMPs, SOPs, FDA, and DEA guidelines. This position requires the ability to work 40 hours per week and overtime as required.
- Follow Master Batch Records for the 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 packaging equipment.
- 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 Requirements
- 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) packaging and/or packaging serialization pharmaceuticals, and/or others dosage forms.
- 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 functional/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.
Highly Desired Skills/Qualifications:
- 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
- Root cause analysis/problem solving tools and techniques
Supervisor Responsibilities (if applicable)
The Pharmaceutical Process Specialist has no direct reports but may be required to support operations frontline supervision/management.
Purdue Pharma L.P. & its Subsidiaries are an Equal Opportunity (EEO) and Affirmative Action Employer encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, national origin, religion, age, sex, sexual orientation, marital status, gender identity, genetic information, disability, military, protected veteran status, or any other characteristic protected by local, state, or federal law. Protected veterans and qualified individuals with a disability may request a reasonable accommodation by emailing: email@example.com.
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- Job Family Technical Operations
- Pay Type Hourly
- Purdue Pharmaceuticals L.P. Technical Operations, 4701 Purdue Drive, Wilson, North Carolina, United States of America