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Associate Director, Process Engineering - Commercial Drug Product

Employer
Moderna, Inc.
Location
United States of America
Start date
May 25, 2023

View more

Discipline
Engineering, Marketing, Manufacturing & Production
Required Education
Bachelors Degree
Position Type
Full time

Job Details

The Role:

Moderna is seeking an Associate Director of Process Engineering Drug Product based in Norwood.

Reporting to the Sr. Director of F&E, the Process Engineer will be responsible for ensuring operability and reliability of GMP drug product, Aseptic Filling, Automatic Visual Inspection, Labeling and Secondary Packaging manufacturing process equipment located at the Moderna Commercial DP manufacturing Facility . This individual will work with closely with Facilities and equipment end users to investigate and troubleshoot issues related to process equipment. Applicants should enjoy working in a fast-paced, dynamic, and innovative environment.

Demonstrated project management skills, in particular engineering and qualification projects from conception to completion. Proven problem-solving skills with a pro-active, field-based approach for project and deviation management required. Ability to develop and drive continuous improvement initiatives is essential. Strong technical writing, problem solving skills, data analysis, and development and implementation of effective corrective and preventative action based on investigations is required.

Heres What Youll Do:

  • Supervise and lead Process Engineers responsible for Drug Product Manufacturing support for the Moderna Commercial DP Manufacturing Facility. Provide technical guidance, coaching, and work prioritization assistance with cross functional engineering teams.

  • Provide direct engineering support and Subject Matter Expertise for drug product process equipment in use (formulation vessels, Barrier Isolator based Aseptic Filling Lines, Automatic Visual Inspection, packaging, and labeling systems, etc.).

  • Drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.

  • The AD Process Engineering will participate on project teams through all phases of engineering projects related to process equipment including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.

  • Troubleshooting equipment to determine root cause of failure modes, owning Corrective/Preventative Actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.

  • The candidate must be able to drive results on multiple complex assignments simultaneously with minimal required direction from their supervisor, in addition to reviewing and guiding the work and performance of contractors.

  • Supports regulatory audits with coaching from subject matter experts.

  • Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion

  • Provide project management of initiatives within Process Engineering. Practices and promotes safe work habits and adheres to safety procedures and guideline

Heres What Youll Bring to the Table:

  • Bachelors degree in Chemical or Mechanical Engineering

  • Minimum education requirement is a bachelors degree, preferably in Sciences or Engineering with 10+ years of experience as a Process Engineer

  • 10+ years of experience in a GxP biopharmaceutical operations environment preferred

  • Experience with Bioprocess Equipment (formulation vessels, Barrier Isolator based Aseptic Filling Lines, Automatic Visual Inspection, packaging, and labeling systems, etc.)

  • 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 investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.

  • A comprehensive understanding of regulatory requirements and their applications in a cGMP environment

  • Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.

  • 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 Modernas interests, objectives and policies in a professional and responsible manner.

  • Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements

  • Experience interacting with representatives of regulatory agencies

  • Experience with facility, utility, systems, and equipment commissioning and qualification

  • Excellent written and oral English language skills

  • Project management experience

  • People management experience

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 year-end shutdown
    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!

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 a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!


Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.


Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.


Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.


Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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Company

Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. Moderna’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.

mRNA is now a turning point in the history of science, medicine, technology, even humankind itself. With this breakthrough discovery, many of the world’s biggest and most challenging medical problems are no longer a question of “how?” but merely a question of “when?”

Come with us as we pursue the uncharted reaches of possibility and make your mark on the future of medicine.

 

Stock Symbol:

MRNA  

Stock Exchange:

USNASDAQ GS

 

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Company info
Website
Phone
617-714-6500
Location
200 Technology Square
Cambridge, MA
United States

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