Contract to Hire
Based in RTP – North Carolina
Responsible maintaining an advanced level of knowledge/understanding of the current Good Manufacturing Practices (cGMP) and Parenteral Manufacturing / Operations and Practices. Additionally, person is expected to continue expanding Process/Equipment Qualifications and to execute the manufacturing of parenteral drug products- in accordance with cGMPs, Company Policies/Performance Expectations, and Environmental Health and Safety Requirements.
Primary Responsibilities and General Role Description
• Demonstrate independent operational proficiency Area Operations such as (e.g., Component Preparation, Portable Vessel(s) Preparation, Compounding, Filling, etc.).
• Provide general area support for assigned process operations; (e.g., Filling, Compounding, Filtration, Capping, Interior Vial Washer, or Tray Loader, etc.).
• Learn & demonstrate advanced understanding of cGMP, parenteral manufacturing, parenteral facility operations, and operating practices.
• Provide operations support for Engineering, Technology Transfer, and Validation Activities.
• Participate in the execution of daily PF logistics activities, assigned on a periodic/rotational basis. Examples of these activities include:
• Posting of area and equipment signs and ensuring they are (i) posted, and (ii) accurately reflect activities/status;
• Maintaining the area in a state of audit-readiness and inform Management Team of problems. Periodic Cleaning / Decontamination of Process Equipment;
• Recommend operational adjustments as identified during troubleshooting, and is able to understand and follow established area practices and procedures for making such adjustments.
• Maintain detailed written records of process adjustments or operational manipulations needed to resolve problems.
• Filter Integrity Test Units
• Basic hand tools, ladders
• Hand Held Portable Instruments
• Required PPE
• Hand-Trucks/Pallet Jacks
Working Conditions- Aseptic Technicians may encounter periodic exposure to:
• Moving mechanical parts,
• Cleaning / sanitization chemicals and associated fumes,
• Moderate noise levels,
• Compressed gasses (Process Air, Nitrogen), and steam,
• Hot equipment surfaces and/or fluids
• Physical demands; e.g., sitting, standing, walking, crawling, climbing, stretching, bending, lifting/moving loads up to 50-Lbs,
• Parenteral Manufacturing Unit Operations (e.g., Component Preparation, Compounding, Filling Operations, Inspection, or Packaging);
• cGMP (SOP’s, Compliance, Batch Records, Documentation)
• Technical Writing-need to be able to read, understand and provide technically-accurate procedural red-lines as changes are recognized;
• EHS (Emergency Program, Hazard Communication, Hearing Conservation, Ergonomics, PPE, and Environmental Monitoring)
• Computer Skills (MS Windows, MS-Word, Excel, PowerPoint ) Lotus Notes, Training System (SOP Reading, Training Requirements), SAP, HMI (Screen Navigation), Maximo, ParCS
• Team-orientation // willingness to provide and receive personal coaching from colleagues, peers, and management team members
A 4-Yr, BS, Technical Degree may be considered as equivalent Pharmaceutical Manufacturing Experience
• Aseptic Level III 5+ Yrs GMP Manufacturing / 5-Yrs (Min) Aseptic/Parenteral;
HOURS 6:00AM – 4:30PM. Occasional OT and weekends. Must have experience operating and setting up equipment. ASEPTIC EXP required.
Company offers an extremely exciting 12+month Consulting Assignment and competitive hourly rate.
For immediate consideration, please email resume to email@example.com