Posted in Management 30+ days ago.
The Role:
Moderna is seeking a Manager of Engineering Services based in Norwood, MA.
Reporting to the AD of Engineering, the Manager of Engineering Services will be responsible for supporting the Facilities, Engineering, and Validation teams with compliance related cGMP activities such as Deviations, CAPAs, Change Controls, and Risk Assessments. The role will also be responsible for Engineering documentation management, including, but not limited to, Engineering Turnover Packages, Site Drawings, P&IDs, and CAD drawings. Additional responsibility includes execution of improvement initiatives within the Facilities, Engineering, and Validation organization.
This role will also be responsible for the management of the Engineering Services team, which includes, Engineering Services Engineers, Engineering Documentation Managers, and CAD drafters.
Here's What You'll Do:
Supervise and lead Engineering Services Engineers, Engineering Documentation Managers, and CAD drafters. Provide technical guidance, coaching, and work prioritization assistance with the team.
Utilizes Facilities & Engineering knowledge and investigational skills to identify and resolve issues to drive continuous improvement
Conducts complex document revisions and/or document management including SOPs, work plans, calibration specifications
Maintains the GMP state of regulatory drawings / documents
Works independently with minimal supervision and direction
Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion
Creates and presents trending and metrics reports for quality events
Provide project management of initiatives across the Facilities & Engineering organization Practices and promotes safe work habits and adheres to safety procedures and guideline
Here's What You'll Bring to the Table:
Bachelor's Degree or equivalent experience with minimum of 10 years of experience in biopharmaceutical operations
A comprehensive understanding of regulatory requirements and their applications in a cGMP environment
Minimum of 5 years' experience with deviation/investigation management systems or a similar technical writing system in a cGMP environment
Excellent written and oral English language skills
Bachelor's degree in Sciences is preferred
Demonstrated ability to lead cross functional teams and deliver results with minimal supervision
Ability to manage multiple competing priorities in a fast-paced environment
Experience working with electronic systems and thorough understanding of 21 CFR part 11, 210, and 211 requirements
Experience interacting with representatives of regulatory agencies
Project management experience
Here's What We'll Bring to the Table:
About Moderna:
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. 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 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 auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six 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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