What are the responsibilities and job description for the Sr. Manager, Automation Engineering position at ModernaTX, Inc.?
The Role
Moderna is seeking a Sr. Manager, Automation Engineering, to serve as a key role owning the delivery and administration of electronic batch records and automated recipes. The individual will be responsible for the design, deployment and continuous improvement of our integrated digital shop-floor recipes supporting drug substance manufacturing operations.
This role will reside at the Norwood manufacturing site and will play a key role driving the continued evolution of our native digital manufacturing platform. As we continue to build our clinical pipeline, this position requires a strong balance of innovation, operational discipline, and proactive collaboration with Digital peers and all levels of leadership. This role requires strong understanding of technology transfer in order to leverage digital systems to rapidly introduce electronic recipes and systems to clinical and commercial manufacturing.
Here's What You'll Do
Here's What You'll Need (Minimum Qualifications)
Here's What You'll Bring to the Table (Preferred Qualifications)
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
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.
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Moderna is seeking a Sr. Manager, Automation Engineering, to serve as a key role owning the delivery and administration of electronic batch records and automated recipes. The individual will be responsible for the design, deployment and continuous improvement of our integrated digital shop-floor recipes supporting drug substance manufacturing operations.
This role will reside at the Norwood manufacturing site and will play a key role driving the continued evolution of our native digital manufacturing platform. As we continue to build our clinical pipeline, this position requires a strong balance of innovation, operational discipline, and proactive collaboration with Digital peers and all levels of leadership. This role requires strong understanding of technology transfer in order to leverage digital systems to rapidly introduce electronic recipes and systems to clinical and commercial manufacturing.
Here's What You'll Do
- Lead recipe developers in the deployment and support of all shop floor manufacturing processes.
- Participate in the Technical Transfer of new products and process from Tech Dev an into Manufacturing and throughout manufacturing lifecycle
- Identify opportunities to improve existing processes and systems by utilizing industry best practices.
- Oversee DeltaV and Syncade recipe design and authoring by following best practices and perform impact assessment
- Understanding of recipe architecture and operations and related components (e.g. software, S88/S95, etc.)
- Provide direct Tier 2 support of operations with troubleshooting and issue resolution with respect to batch execution
- Participate in validation activities in conjunction with Validation, Manufacturing, and QA related to implementation and on-going support
- Support and guide initial deployments and routine upgrades, risk assessments, and testing activities
Here's What You'll Need (Minimum Qualifications)
- Bachelor's degree in Engineering, Computer Science, or other technical degree.
- Minimum 8 years of experience authoring automation recipes and MES electronic Batch Records.
Here's What You'll Bring to the Table (Preferred Qualifications)
- Deep understanding of cGMP and manufacturing operations and practices.
- An understanding of Good Automated Manufacturing Practices (GAMP) and Computer System Validation (CSV).
- Excellent interpersonal and communication skills with ability to work collaboratively within a team of cross functional stakeholders to influence decisions at every level of the organization.
- Self-directed with effective analytical and problem-solving skills. Must be able to drive results on multiple complex assignments simultaneously in a fast-paced environment.
- Strong communication skills (verbal and written).
- Experience designing recipes based on ISA 95 and ISA 88 standards and best practices.
- Demonstrated ability to work independently and collaboratively on cross-functional teams.
- Deployment experience with plant floor recipe execution systems (MES/DCS) solutions (e.g. Emerson Syncade/DeltaV, Rockwell PharmaSuite/PlantPAX, Werum PAS-X)
- Experience with Emerson Syncade MES and DeltaV DCS is preferred.
- A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
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
• Discretionary winter shut down
• Paid sabbatical after 5 years; every 3 years thereafter - Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
- 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-BB1
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