1. Provide direct support in the control and preparation of large scale media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation/sterilization of process equipment using a GMP Parts washer and autoclave.
2. Provide manufacturing expertise for functions supporting the manufacture of preclinical, phase I and phase II clinical trial materials within a cGMP Biologics Pilot Plant, including assisting in the transfer of new technologies/processes, operation, and troubleshooting of equipment, preparation, and close-out of documentation, and ensuring compliance to relevant regulations.
3. Provide assistance with the development and qualification of washer cycles, load pattern configurations and sterilization packaging techniques.
4. Support change control and (re) qualification related testing for all equipment/systems, and supports Validation protocol development (IQ, OQ, PQ), execution, assessments, data reviewing specifications, procedures, protocols and final reports preparation.
5. Responsible for supporting and executing the coordination of equipment maintenance, calibration, and validation with appropriate internal departments.
6. Provide cross-functional support for other departments within the pilot plant at the discretion of management
7. Collaborate with Planning/Purchasing in creating SAP purchase orders for procurement of raw materials and components.
8. Support the supply chain logistics including oversight of material movements external and internal to the facility working closely with Warehouse staff. Works with outside suppliers to store and retrieve materials based upon manufacturing schedule. Determines capacity requirements for raw materials, intermediates, and product.
9. Support the preparation of bill of materials, batch records, SOPs, and close-out reports for each campaign.
10. Provide technical expertise and contribute in troubleshooting product and equipment issues and deviations. Provide timely reporting, investigation, and resolution of manufacturing deviations, change control, and corrective/preventive actions.
11. Ensure adherence of operations to cGMP, ICH, EMEA and JP Guidelines as well as industry safety standards and OSHA guidelines.
12. Interact cross-functionally with Production Operations, Facilities, R&D, Quality Assurance, Quality Control, Project Management, Procurement, and Finance and other internal and external functions to play a critical role in the support of successful product development.
The individual will play a critical role in the qualification/validation of equipment routine operation, and change management with Support Operations of the Client Biologics pilot plant whose purpose is to produce material for toxicology, phase I and phase II clinical trials to support Client’s clinical development pipeline. Specifically, this person will contribute to the success of the operation by providing technical expertise for equipment and processes that support manufacture of materials for global clinical supplies.
The individual will also be responsible to maintain and/or enhance the production area processes supporting media/buffer manufacturing, raw material and component planning, procurement, and to remain compliant to regulations.
Education: BS in Biological/Chemical/Physical sciences, or Engineering is a must
• Minimum of 3-5 yrs in a multi-discipline cGMP environment, commissioning and operating equipment in Support production areas.
• Minimum of 1-2 yrs experience in SAP at a pharmaceutical or bio-technology company preferred.
• Proficient in the operation of all area specific production equipment such as washer, autoclave, and disposable mixing technology for media and buffer solutions.
• Must be willing to work any shift in supporting 24/7 bulk operations that may include weekends, holidays and overtime, as required.
• Must be able to sit and/or stand for extended periods of time and be able to lift 25 lbs.
• Self-starter with a strong focus on detail, safety, quality and results.
• Ability to multi-task and adjust to varying priorities to meet timelines.
• Ability to identify, investigate, and trouble-shoot basic process and equipment problems.
• Working knowledge of cGMP, EMEA, and JP regulations.
• Good written and communication skills.
• Good problem solving and interpersonal skills with the ability to work in a team environment required.
– Knowledge of GMP guidelines
– Experience with media and buffer preparation
– Disposable mixing technology or stainless steel technology
– SAP experience
– Pilot Plant experience preferred
– Autoclave wash
Source: Job Diva – Job Listing