Coating Operation Technician – First ShiftUSA, Middletown,Delaware
Datwyler Sealing Solutions is a leading supplier of customer-specific sealing, closure, and packaging solutions to global market segments, such as the Automotive, Health Care, Civil Engineering, and Consumer Goods industries. We are always looking for talented, highly qualified employees at all levels of our organization. Datwyler offers the opportunity to join exciting industries and to be part of a highly esteemed brand. From production staff to client advisors, from technology experts to design engineers, from China to Mexico: at Datwyler, our employees will experience diversity in a way that only an international company can provide. We focus on helping talents reach their full potential – professionally and personally. Our working environment is shaped by our values and beliefs: we are entrepreneurs, we bring value to our customers, we excel in what we do and we have respect for others. With 17 operating sites and around 6,000 employees, Dat-wyler Sealing Solutions generates an annual revenue of approximately EUR 750 million. Based on a strategic decision, we are looking for a…
Coating Operation Technician – First Shift
Description: The coating operational technician will operate a variety of highly complex automated production equipment used to coat medical device components via a proprietary process to serve the high-end pharmaceutical market. The candidate will serve as the lead operator in a state-of-the-art new manufacturing facility and must become an expert in all steps of the production operation from start to finish.
• Operational duties and demands of all automatic and semi-automatic production equipment in the area of responsibility as well as training of new operators and assist in development of operational and training procedures.
• Complete tear down and re-assembly of equipment for cleaning as part of day-to-day maintenance or daily start-up.
• Communication with the paper-less production control system so work orders are managed accurately and in a timely manner.
• Raw material handling and dosing.
Along with the ability to operate equipment, the candidate shall also:
• Follow safety procedures at all times while working in a classified hazardous area.
• Understand and work with respect to GMP requirements and ability to perform duties in a regulated environment.
• Understand and follow the proper techniques for sterile processing of regulated medical products.
• Follow work schedules and attendance guidelines, and participate in HR procedures applicable (appraisal, training, team meetings).
• Handle raw materials from the production storage area to the manufacturing area and follow correct procedures/SOPs to load and unload equipment.
• Monitor equipment and process parameters, and take actions necessary to maintain process without direct supervision.
• Perform quality control tests and input results into the batch records using a paper-less documentation system.
• Assist in development of SOP’s for the production process and quality control checks.
• Take samples, and perform in process quality checks and input results into paper-less system.
• Display and promote positive safety behaviors at all times, use of proper personal protective equipment, tools, and equipment to ensure that safety is maintained and upheld at all times.
• Perform day to day maintenance tasks in accordance with the appropriate quality system guidelines and using SOP’s where applicable.
• Associates degree in a technical field such as: Engineering technology, industrial maintenance, operations management, production operations.
• 3 years or more experience working in an ISO class 8 or cleaner manufacturing environment.
• 3 years or more experience with GMP and FDA regulation in a manufacturing environment.
• 2 years or more experience in medical device manufacturing or pharmaceutical manufacturing facility.
• Experience or knowledge of hazardous areas such as Class I Div II explosive environments.
• High school education or equivalent.
• 4 years or more experience in a fast paced, manufacturing environment.
• Ability to work in a clean room environment and perform essential job functions wearing appropriate gowning for grade of environment.
• Desire to lead and train others, cross-train in other departments and skill sets.
• Ability to work as a team or individually, in rotating shifts, and coordinate multiple resources without direct supervision.
• Basic mechanical skills, use of hand tools, making minor tuning adjustments to equipment as needed to keep process running.
• Ability to operate tablet computers, use of software such as MSOffice and SAP.
• Ability to lift 40 lbs. 20/20 vision with or without corrective lenses.
• Able to operate in a “shift work” schedule and occasionally work over time.
• Able to stand for duration of shift.
• Travel overseas for training for a period no less than 2 weeks will be required within the first month of hire. Travel thereafter will be minimal.
• Valid passport, ability to travel internationally.