Job description
The Role:Reporting to the Associate Director, Process Engineer, the Process Engineer will be responsible for ensuring operability and reliability of GMP Drug Product manufacturing process equipment located at the Moderna clinical manufacturing facility in Norwood, MA. This individual will act as the System Owner of the mRNA process Drug Product manufacturing equipment throughout its lifecycle by working closely with Manufacturing, Facilities & Engineering, MS&T, Quality, EHS, and other applicable disciplines. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.
Here’s What You’ll Do:
The System Owner will be responsible for ensuring the process and process equipment meet compliance, safety, and business requirements on a day-to-day basis, as well as respond to alarms, Out of Specs, Out of Tolerances, etc. to ensure product impact assessments are performed as necessary.
Troubleshoot equipment to determine root cause of failure modes, own Corrective/Preventative Actions & associated change controls, provide input on preventative maintenance plans, assess change controls, and spearhead continuous improvement initiatives.
Owns and maintains process equipment assets through CMMS (maintenance strategy, spare parts, WO workflow, CMMS Change Control assessment).
Own quality records such as Change Controls, Deviations, and CAPAs related to manufacturing process equipment, and employ high quality technical writing within the required quality systems to ensure the manufacturing schedule is not impacted.
Maintain Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
Acting as an owner, provide engineering support for process equipment procurement and start-up and CQV at Moderna’s Norwood Clinical manufacturing facility (Aseptic Filling Line for vials and Syringes, Filling Isolator, Formulation, Analytical Equipment, Automatic Inspection, Label and Secondary Packaging, Compounding and Component Prep equipment such as Parts Washer and Autoclave.
The System Owner will participate on project teams through all phases of engineering projects related to process equipment including development of user requirements, conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
Review design documentation from conceptual through detailed design, URS documents, and Engineering Turnover Packages, including specifications, component lists, operating manuals, and drawings for GMP process equipment and update as required.
Here’s What You’ll Bring to the Table:
A bachelor’s degree in Electrical or Mechanical Engineering or any other life science related technical field
Minimum of 0-2 years relevant experience as a Process Engineer or System Owner in a Drug Product manufacturing environment.
Experience in a GxP environment preferred
Knowledgeable on GMP Regulations for Aseptic Filling, Parenteral Visual Inspection and Track & Trace
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 be able use his/her technical background to make informed decisions and ensure manufacturing demands are met.
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
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
Highly competitive and inclusive medical, dental and vision coverage options
Flexible Spending Accounts for medical expenses and dependent care expenses
Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
Family care benefits, including subsidized back-up care options and on-demand tutoring
Free premium access to fitness, nutrition, and mindfulness classes
Exclusive preferred pricing on Peloton fitness equipment
Adoption and family-planning benefits
Dedicated care coordination support for our LGBTQ+ community
Generous paid time off, including:
- Vacation, sick time and holidays
- Volunteer time to participate within your community
- D iscretionary year-end shutdown
- Paid sabbatical after 5 years; every 3 years thereafter
401k match and Financial Planning tools
Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
Complimentary concierge service including home services research, travel booking, and entertainment requests
Free parking or subsidized commuter passes
Location-specific perks and extras!
Candidates should be aware that Moderna currently maintains a policy requiring all US-based employees to be fully vaccinated against COVID-19 and receive a booster shot once eligible . Newly hired employees must be vaccinated and boosted prior to their employment start date. Moderna is an equal opportunity employer and will provide a reasonable accommodation to those unable to be vaccinated or receive a booster where it is not an undue hardship to the company to do so as provided under federal, state, and local law.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and autoimmune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com .
Moderna is a smoke-free, alcohol-free and drug-free work environment.
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. #LI-NB1
-
abouteureka.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, abouteureka.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, abouteureka.com is the ideal place to find your next job.