GMP TECHNICAL SPECIALIST

Company: Sever Pharma Solutions
Location: Putnam
Posted on: March 20, 2023

Job Description:

Job Description:

Job Description Summary The GMP Technical Specialist is responsible for the day-to-day setup, operation, disassembly and cleaning of pharmaceutical equipment in both R&D and GMP manufacturing environments. All work is to be completed in a compliant fashion in accordance to current Good Manufacturing Practices (cGMP) standards, FDA regulations (particularly 21 CFR Parts 210 & 211), and Foster Delivery Science procedures and requirements. Essential Duties & Responsibilities - Ensures all work is performed in compliance to cGMP, FDA and company requirements; documentation is complete and accurate. - Assists in the cleanliness of production areas and equipment while ensuring procedures are followed and the area meets all requirements for audit readiness. - Must wear and abide by all safety precautions and wear the necessary personal protective equipment for a given process. - Must understand and follow instructions detailed in Development Records, Batch Production Records and Packaging Records. - Must be able to work in a fast-paced, priority changing environment. - Must possess mechanical aptitude and equipment knowledge to be able to assist in troubleshooting equipment issues. - Knowledge of disassembly, assembly, cleaning and operation of pharmaceutical equipment within a clean room setting, particularly extrusion equipment. - Manage raw material, equipment and product inventory and warehousing, as necessary. - Flexibility to work overtime, potentially on short notice. Basic Qualifications - High School Diploma with at least 5 years' experience in medical device and/or pharmaceutical manufacturing; equipment handling and the operation of in an FDA-compliant environment - Higher education may be used in lieu of experience - Working knowledge of Microsoft Word, Excel, PowerPoint - Demonstrate attention to detail, problem solving and the ability of multi-tasking and prioritizing - Great written and verbal communication - Working knowledge of pharmaceutical GMPs and FDA regulations - Must be able to work in a pharmaceutical clean room environment - Able to use a variety of hand and power tools - Must pass a baseline medical and pulmonary test Preferred Qualifications - Able to work in a dynamic, fast-paced environment - Good trouble shooting and problem-solving skills - Working knowledge of extrusion with polymers and/or pharmaceutical materials Work Environment - Must be able to lift up to 50 lbs - Will require working in clean room, pharmaceutical manufacturing environment including the use of gowning and other PPE including but not limited to the use of PAPRs - May be exposed to high noise environments - As noted, a baseline medical and pulmonary exam will be required Monday through Thursday 6 am to 3:30 pm, Friday 6 am to 10 am PI207846893

Keywords: Sever Pharma Solutions, New England , GMP TECHNICAL SPECIALIST, IT / Software / Systems , Putnam, Northeast