(Contract) Technician IV, Facilities
Based at our new GMP Manufacturing facility in Norwood, MA, reporting to the Senior Director, Facilities & Engineering, this position will be responsible for maintenance and repairs of GMP/non-GMP process and support equipment. This position will also support troubleshooting, investigations and reliability engineering for GMP/non-GMP process and support equipment. This position will be the first responder to equipment issues and must follow through to ensure resolution by either self-performing the work or directing the activities of service providers.
Here's What You'll Do:
- Perform preventative and corrective maintenance activities including simple calibrations as directed by schedule on all process equipment and systems, with established procedures and/or approved practices. Lead efforts in developing remediation for follow-up and emergency work.
- Troubleshooting on equipment and systems, including development of remediation activities for issues with multiple systems and equipment and repair malfunctioning equipment. Work with equipment owners/engineers and direct the performance of work by equipment vendors.
- Maintain cGMP records, both paper based and electronic.
- Understand Asset Management and routine reliability concepts
- Provide subject matter expertise for the operation and maintenance of manufacturing and support systems/equipment such as autoclaves, washers, TFF, Chromatography Columns and skids, mixers and stainless tanks.
- Maintain Facilities SOPs as required. Perform revisions and maintain author/owner responsibilities.
- Lead performance of maintenance activities and small projects.
- Provide “on-call” support on a rotating basis. Support regular 24-7 operation of facility and respond to facilities issues as needed.
- Maintain Qualified Trainer qualifications on OJTs assigned. Develop OJT records.
- Support and own Change Controls, CAPAs and Deviations
- Ensure that spare parts, tools and equipment are available to complete all assigned tasks
- Respond to alarms and document activities. Working with equipment owners, develop remediation activities for alarms.
- Manage contract service providers; including scheduling, training on required SOP's, coordination and ensuring all work and documentation is performed in accordance with cGMP requirements.
- Administer and perform hazardous energy control procedures and confined space entry
- Other duties as required
Here's What You'll Bring to the Table:
- At least 5 years relevant experience working in a regulated (cGMP preferred) environment. Thorough understanding of OSHA regulations related to LOTO, MSDS, Confined Space and Hot Work.
- Post-secondary degree in a science/technical field or a technical trade school degree.
- Military training equivalent of above is acceptable.
- Experience with Metrology preferred.
- Understanding of PLC controls for simple troubleshooting is required.
- Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.
- Must have a customer service mindset.
- Must be able use his/her technical background to investigate issues using a structured problem solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to find true root cause and path forward for complex problems.
- Demonstrated ability to learn new equipment/systems.
- Familiarity with Excel, Word, and PowerPoint are required.
- Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
- Ability to represent Moderna's interests, objectives and policies in a professional and responsible manner.
Why join Moderna Therapeutics
We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching. It could transform not only how certain diseases are treated but also how medicines are discovered, developed and manufactured - at a breadth, scale and speed not common in the biopharma industry.
Since our founding in 2011, we have built the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and speed early development, a rapidly expanding pipeline, and an unparalleled team. Our development pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials already underway with other development candidates progressing toward the clinic. In addition, we have a number of discovery programs that are advancing toward the development stage.
We invite you to explore our site to learn more about our company and how we are advancing the promise of mRNA science to improve health and impact lives around the world.
Deliver on the promise of mRNA science to create a new generation of transformative medicines for patients.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.