Pharmaceutical Process Specialist, Packaging, 1st shift (M-Th: 6:00am - 4:30pm)
and its subsidiaries develop, manufacture and market medications and consumer health products to meet the evolving needs of healthcare professionals, patients, consumers and caregivers.
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 welcome the opportunity to have you on our team!
Our Commitment to Diversity, Equity, Inclusion and Belonging
We are driven by our purpose: Compassion for patients and excellence for science inspire our pursuit of new medicines.
Diversity, Equity, Inclusion and Belonging are important to our business and are articulated in our People and Culture strategy and represent an important component of our goals and objectives. As we build an exciting path forward, we strive to create an environment where everyone can bring their best and true self to work each day. Embracing different backgrounds, ideas, and viewpoints are valued and encouraged. We believe that Respect is grounded in our Values of Integrity and Courage, underpinned by Innovation, and always in Collaboration with each other. Together we make an impact on our growth, our culture, and most importantly, patients.
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.
Our Company is an Equal Employment Opportunity/Affirmative Action employer, Minority/Female/Disability/Veteran, encouraging diversity in the workplace. Qualified applicants will receive consideration for employment without regard to their race, gender, national origin, religion, color, age, sex, sexual orientation, pregnancy, marital status, gender identity or expression, genetic information, disability, veteran or military status, or any other characteristic protected by local, state, or federal law.
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- Job Family Technical Operations
- Pay Type Hourly
- Purdue Pharmaceuticals L.P. Technical Operations, 4701 International Blvd. W., Wilson, North Carolina, United States of America