The role of the manufacturign operator is to perform production activities including Equipment preparation, Formulation, Filling, Inspection, and Packaging. Collaborates effectively with other functional groups to ensure production goals are achieved and investigations are completed in a timely manner.
- High school education or equivalent.
- BS in Biology, Microbiology, Chemistry, Bio-Tech or Engineering preferred (current students may apply).
- Experience in an aseptic manufacturing environment preferred.
- Must be familiar with a variety of production equipment.
Line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment
- Operate and maintain production equipment.
- Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities.
- Execute validation protocols for processes and equipment.
- Maintain records and a clean environment to comply with regulatory requirements.
- Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.
- Review/update current SOPs as well as write new SOPs.
- Lead troubleshooting and process improvement activities including corresponding documentation activities.
- Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance.
- Initiate appropriate action when process deviations occur.
- Perform on job training for new and developing operators.
Other duties as assigned by leadership team.
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Under the direction of the Facilities Engineering Manager with guidance and/or working with Facilities Maintenance Technicians II and III, the Facilities Maintenance Technician I performs preventive maintenance, inspections, installations and repairs on all assigned equipment to ensure their proper operation and function. The assignments may include general building maintenance, light carpentry, painting, changing light bulbs, repair of minor electrical devices, light plumbing or HVAC according to the persons training and experience.
- Performs preventative maintenance, inspections, installations and repairs on assigned equipment to ensure their proper operation and function.
- Performs all assignments in a competent and timely manner
- Performs as a reliable member of the Preventive Maintenance Program which includes routine inspections, basic installations and minor repairs.
- Performs general building maintenance which may include light carpentry, painting, light plumbing, changing of light bulbs and repair of minor electrical devices.
- Participates in departmental on-call program as designated.
- Working conditions may include but not be limited to confined spaces, heights, climbing ladders & stairs and lifting heavy items.
- Maintains all records, such as work orders, and necessary reports to ensure accurate recording of activities for regulatory purposes.
- Processes work requests and turns in completed work requests in a timely and professional manner.
- May be required to electronically process and close work orders.
- Ensures proper care of equipment and tools issued for maximum safety and productivity and adheres to all personal safety requirements.
- Maintain all tools and equipment in clean, safe, working order.
- Maintain adequate inventory of related parts to perform assigned duties.
- Maintain technical skills and required certifications to perform job duties.
- Adhere to all safety requirements and wears the proper Personal Protective Equipment required by the job.
- Responds to emergency situations to ensure employee, patient and facility safety.
- Champions overall safety in the department. Reports possible safety issues and recommends appropriate changes.
- Complies with OSHA, and other local, state and federal regulations.
- Communicate effectively with Managers, Facilities Maintenance Lead Technician and other Facilities Maintenance Technicians on a regular basis, formal and informal, to discuss possible changes or problems with the Facilities and Preventive Maintenance operation or equipment.
- Perform other position appropriate duties as required in a competent, professional and courteous manner.
- Education: High School Diploma or GED required
- Specialized vocational courses preferred
Training and Experience:
- 1+ years’ experience and/or education preferred
- Working knowledge of computerized PM and work order systems
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Formulation FRD Scientist
Formulation Scientist is responsible for formulation development of sterile injectable dosage forms from pre-clinical development through product commercialization. Formulation Scientist will maintain a moderate level of expertise within their field and develops new technologies to be applied in the development of drug products. They will design studies related to pre-formulation and formulation of parenteral products, including solubility, pH solution stability, lyophilization, suspension development, polymer development and others that may impact the stability and delivery of the product. This includes experimental design, data evaluation, generation of scientific reports, and coordination studies with other technical groups. Responsible for the development and evaluation of proposed formulations, processing, compounding procedures, and selection of container/closure systems. Demonstrates the ability to provide technical procedure/direction and interact professionally and effectively with management, peers, team members, supervisors, and outside customers on an ongoing basis to ensure product development success. Plays an important role in the scale-up and technology transfer process in collaboration with Manufacturing Plant and Production personnel. Investigates, troubleshoots and resolves issues associated with formulation studies and/or R&D pilot manufacturing. Responsible, in collaboration with management, to develop and track project timelines and assumes departmental responsibilities for projects when necessary. Consults and interacts closely with internal cross-functional teams and external clients and customers. Collaborates with Process Engineers, Manufacturing Operators, Quality Control, Microbiology, Validation, and QA departments to coordinate pilot, registration, and commercial batch manufacturing.
- Proven track record in parenteral formulation development and process transfer in support of sterile drug product manufacturing through DOE concepts. Experience in the design and execution of high quality experimentation leading to the generation of QbD data.
- Experience in solubility enhancement technologies for parenteral formulations, including successful experience with formulation development of clinical and generic candidates.
- Demonstrated ability to operate equipment and apply analytical methodology utilized in the formulation development of parenteral dosage forms (e.g. lyophilizers, compounding/filling equipment, mixing techniques, sterilization techniques, HPLC, KF, particulate matter, etc.)
- Apply and provide feasibility assessment for a variety of scientific principles and concepts to potential clients, products and investigations.
- Conducts literature searches to support formulation development and/or pilot manufacturing documentation.
- Active participation on departmental and/or cross-functional teams as a departmental representative.
- Multitask effectively while performing multiple formulation development projects.
- Develop formulation/manufacturing processes for tech transfer to Operations in support of GMP manufacturing
- Assist, consult, and trouble-shoot during process transfer scale-up and validation activities.
- Effectively communicates and defends own work, orally and in writing, at team meetings, in technical documents, and to external partners.
- Interact with cross functional departments including Business Development, Project Management, ARD, QC, Process Development, Quality, Operations and with external clients.
- Comfortable working with external clients, to supplement internal expertise and methodologies; proven ability to recognize internal limitations and make recommendations to external clients.
- Excellent problem solving skills, with ability to anticipate and strategize proactively to minimize potential issues
- Ability to work in a fast paced, complex, environment and adjust to changing priorities
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