Aseptic Manufacturing Associate/Manufacturing Project Specialist

Lonza is one of the world’s leading and most-trusted suppliers to the pharmaceutical, biotech and specialty ingredients markets. We harness science and technology to create products that support safer and healthier living and that enhance the overall quality of life.

* Review the design of the facility & equipment and provide support to FATs, SATs & validation * Supporting training with repsect to Cell Therapy operations. (particular emphasis on aseptic filling) * Provide guidance and trouble shooting input during the commissioning, validation & start-up effort. * Support the generation of SOP's and batch records for the Cell Therapy project. (particular emphasis on aseptic filling) * Support the ordering and set-up for new small equipment required to run the area, including ensuring proper documentation is in place * Support activities associated with setting the area up for GMP operation, and that the transition from project to GMP operation is planned for and transitioned smoothly. This will include placing systems and procedures from current operations in place prior to start up. * During the project phase this position will have a schedule of Monday to Friday 8:00am to 4:30pm. * Post project completion this role will transition into a traditional manufacturing schedule. * Potential opportunity for short term international assignment at a sister site to support the business and enhance training * Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times. All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc).

* Must have experience and knowledge of aseptic production processes and be a source of technical expertise. 3+ years of experience in Aseptic Drug Product Filling (for example - vials, syringes, otic/ophthalmic containers) experience is required. Finish experience with drug product primary container visual inspection (automated, semi-automated and manual) is preferred. * Significant manufacturing experience. * High School Diploma is required. Certification, Associates or Bachelor's Degree in a science/technology related discipline is preferred. * Experience with independently writing and executing SOPs and associated batch record documentation; experience with technical writing preferred. * Strong knowledge and adherence to cGMP compliant processing (At least 4 years’ experience) * Demonstrated support to change control process, work order generation, deviation investigation and management * Proven logic and decision making abilities. Including real-time decision making on process events based on knowledge of defined SOPs & policies. * Able to provide manufacturing insight into the review of more complex decisions with supervisor and support departments, plus provide input to management on scheduling or process issues based technical, process & equipment experience. * Able to multi-task on equipment preparation and operations to ensure area stays on schedule * Where required work unsupervised. For example perform shift exchanges independently * Offers suggestions for improvement, implements where appropriate and is keen to develop self with respect to technical knowledge of operations and technologies * Ability to manage multiple priorities and coordinate between departments for multiple parallel activities. * Able to troubleshoot equipment; non-routine as well as routine troubleshooting * Ability to communicate manufacturing operations perspective effectively to management, support department and customers. * Strong mechanical aptitude preferred. * Ability to work collaboratively in a project and cross-functional team environment