Principal Engineer, Drug Product
$142.5k - $256.5kModerna Therapeutics
- # Principal Engineer, Drug ProductApply: Norwood, Massachusetts: Drug Manufacturing: Full time: Posted Today: R19992**The Role:** The Principal Engineer, Drug Product will provide technical leadership and expertise across Moderna’s global manufacturing network, including operations in the United States, Australia, Canada, and the United Kingdom. The role will focus on sterile drug product processes and associated manufacturing technologies, including filling, inspection, packaging, and labeling equipment. This individual will establish global engineering standards in the Technical Authority organization, and drive consistency across facilities, processes, equipment, and systems.This position plays a key role in defining engineering best practices aligned with Moderna’s global manufacturing strategy and providing technical oversight across the manufacturing network. The Principal Engineer will support capital projects, continuous improvement initiatives, and resolution of complex technical challenges while ensuring alignment with regulatory requirements and Moderna standards. The ideal candidate will demonstrate deep expertise in filling, inspection, labeling, and packaging equipment within a regulated environment and the ability to lead and influence cross-functional teams across global locations. **Key Responsibilities:****Global Technical Leadership:** * Lead the development of a Technical Authority organization to support manufacturing operations and provide expert guidance on engineering decisions for drug product processes globally.* Act as the Global Subject Matter Expert (SME) in primary and secondary packaging, inspection, filling, labeling, closing equipment, and processes.* Establish and maintain best practices and functional standards that enable global standardization of facilities, engineering processes, equipment, and systems. **Capital Project Leadership:** * Lead the Front-End Engineering for capital projects, including scope determination, design review, manufacturability assessments, cost analysis, risk evaluation, and schedule planning for Drug Product projects.* Oversee and participate in the complete project lifecycle, including conceptual design, engineering, procurement, construction, installation, start-up, commissioning, validation, and qualification of equipment.* Ensure project documentation is accurate, comprehensive, and compliant with regulatory and internal standards, including URS, functional descriptions, and engineering drawings. **Equipment Specification and Vendor Management:** * Develop and own specifications for filling, inspection, labeling, and packaging equipment, leading the selection and assessment of equipment vendors.* Collaborate with cross-functional teams to define user requirements, design specifications, and process parameters, providing input into risk assessments (FMEA) and operational strategies.* Drive the development of Engineering Turnover Packages, ensuring accurate documentation, operating manuals, and GMP compliance for all process equipment. **Regulatory Compliance and Testing:** * Ensure that all global manufacturing processes comply with regulatory requirements (e.g., GMP, FDA, ICH, EMA), including validation and qualification activities.* Lead Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning of equipment at vendor locations and on-site.* Support global qualification strategies, including vision systems for Automated Visual Inspection (AVI), and troubleshooting equipment failures while ensuring preventive maintenance and continuous improvement. **Innovation and Continuous Improvement:** * Drive innovation by identifying new technologies for filling and closing equipment, primary and secondary packaging, and vision inspection systems.* Lead testing and evaluation of new technologies to support the global technical roadmap, providing solutions for emerging business needs and continuous process improvements.* Act as a technical influencer, providing guidance to senior leadership on business initiatives and strategic capital investments. **Operational Excellence and Problem-Solving:** * Serve as a problem solver for complex engineering challenges, troubleshooting equipment, determining root causes of failures, and driving preventive maintenance initiatives.* Support deviation investigations, change controls, and regulatory audits by providing expertise in process equipment and compliance.* Lead the creation and optimization of machine recipes, and support re-qualification and inspections as needed across global sites. **Required Background:** **Education:** * Bachelor’s or Master’s degree in Engineering or a related technical field; advanced degree preferred. **Experience & Requirements:*** 15+ years of experience in engineering roles within the pharmaceutical industry, specifically with drug product manufacturing equipment such as filling, packaging, and labeling systems.* Proven experience managing large-scale, global capital projects, and leading cross-functional technical teams.* Deep understanding of regulatory and performance requirements for sterile manufacturing processes, including experience in FAT/SAT, commissioning, validation, and qualification.* Demonstrated success in driving innovation, managing equipment vendors, and developing engineering standards across global sites.* Strong leadership and communication skills, with the ability to influence senior stakeholders and lead global technical teams.* Ability to manage multiple complex projects simultaneously while maintaining a focus on strategic objectives. **Our Working Model** As we build our company, we have always believed that an in-person culture is critical to our success. This role is 100% onsite, reflecting the importance of being physically present to support the work, collaborate closely with colleagues, and contribute to our site-based operations.Working onsite enables real-time collaboration, strong team connections, direct mentorship, and the hands-on partnership needed to deliver our mission. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.Moderna is a smoke-free, alcohol-free, and drug-free work environment. **Pay & Benefits****At Moderna, we believe that when you feel your best, you can do your best work.** **That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.*** Competitive healthcare, plus voluntary benefit programs to support your unique needs* A holistic approach to well-being, with access to fitness, mindfulness, and mental health support* Family planning benefits, including fertility, adoption, and surrogacy support* Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown* Savings and investments to help you plan for the future* Location-specific perks and extras The salary range for this role is $142,500.00 - $256,500.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
- J-18808-Ljbffr Moderna Therapeutics
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Principal Engineer, Drug Product in Norwood, MA vacancy
$142.5k - $256.5k
The Role:The Principal Engineer, Drug Product will provide technical leadership and expertise across Moderna’s global manufacturing network, including operations in the United States, Australia, Canada, and the United Kingdom. The role will focus on sterile drug product...SuggestedPermanent employmentFull timeWork from homeModerna Therapeutics
Norwood, MA3 days ago- Moderna is seeking a Principal Engineer, Drug Product to provide global technical leadership for sterile drug product processes across the manufacturing network, including filling, inspection, packaging, and labeling equipment. The role will establish global engineering...Suggested
- Moderna Therapeutics in Norwood, MA, is seeking a Principal Engineer, Drug Product, to provide global technical leadership for sterile drug product manufacturing across sites worldwide. The role focuses on filling, inspection, labeling, packaging equipment and drives standardization...SuggestedWorldwide
- Moderna seeks a Principal Engineer, Drug Product to provide global technical leadership across our manufacturing network, focusing on sterile drug product processes and packaging equipment. You will define engineering standards and oversee capital projects, driving continuous...Suggested
$74k - $118.4k
...motivated Individual, to work in a team developing Moderna’s sterile drug product processes and products that enable clinical and future... ...Bachelor’s Degree in one of the following fields: Chemical Engineering, Biochemical or Biomedical Engineering, Pharmaceutical Sciences...SuggestedPermanent employmentWork from home$89.9k - $143.8k
...the development, implementation, and optimization of internal Drug Product operations including formulation, filling, inspection,... ...needed. Work closely with Quality, Operations, Regulatory, and Engineering teams to support compliant and efficient GMP manufacturing....Permanent employmentFull timeWork at office$145.9k - $234.2k
The Role:Reporting to the Director, Global Drug Product Automation, the Sr. Engineer II, Drug Product will serve as a technical leader responsible for... ...Packaging, Visual Inspection, and related digital systems.The Principal Automation Engineer will provide technical leadership...Permanent employmentFull timeWork at officeWork from homeModerna Therapeutics
Norwood, MA4 days ago- ...The Senior Director, CMC-Drug Product Manufacturing, leads drug product manufacturing activities, overseeing external manufacturing, technology... ...operations. Qualifications PhD degree in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or related...
Corbus Pharmaceuticals
Norwood, MA1 day ago - Scorpion Therapeutics in Norwood, MA is seeking a Senior Director of Drug Product Manufacturing to oversee clinical and commercial drug product activities, ensuring cGMP compliance and readiness for late-stage products. You will lead manufacturing strategy, manage external...
- Scorpion Therapeutics seeks a senior manufacturing leader to drive lead drug product manufacturing for both clinical and commercial programs. You will oversee external CMO/CDMO partnerships, technology transfer, and process validation, ensuring manufacturing readiness...
- ...collective diversity, skills and talents empower us to deliver the best products and solutions for our colleagues, clients and communities. If... ...offer of employment, you will be required to undergo a drug test. ADA Disclaimer: In developing this job description care was...Full timeMonday to FridayShift work
$166.75k - $228.85k
...Position SummaryWe are seeking a highly accomplished Senior Principal Engineer to serve as a senior technical leader and individual contributor... ...years of progressive hands-on experience in medical device product development under FDA Quality System Regulation (21 CFR Part...Full timeTemporary workIntegra LifeSciences
Mansfield, MA1 day ago$147k - $237.5k
...organization is scaling rapidly, and we are looking for world-class Principal Engineers to drive the future of our platform. We are actively hiring... ...aspirations.The Two Areas You Will Be Considered For:Production Engineering (Reliability & Scale)The Core Focus: Ensuring...Full timeRemote workPalo Alto Networks
Boston, MA15 hours ago$192.11k - $202.62k
Basic Qualifications Bachelor's degree in Systems Engineering, or a related Science, Engineering or Mathematics field, plus a minimum... ...NSA-certified Cybersecurity devices in a rapidly growing product line. You’ll be working at the cutting edge of Cybersecurity and...Flexible hoursGeneral Dynamics Mission Systems
Dedham, MA2 days ago$145.9k - $234.2k
The RoleModerna is seeking a Principal Systems Engineer, Digital Lab Systems who will serve a key role supporting the delivery and administration... ...meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal OpportunitiesModerna is...Full timeWork at officeWork from homeModerna Therapeutics
Norwood, MA4 days ago- ...Own the Solution.Join a Team Where Your Ideas Power the FutureAre you an experienced Electrical Engineer who thrives on solving complex technical challenges and taking products from concept to reality? We're seeking a hands-on, highly motivated engineer to join our agile...Full timeImmediate startFlexible hours
Analogic
Canton, MA3 days ago $175k - $201k
...improve the lives of patients and their families.The Perfect Addition to Our TeamYou are a motivated, resourceful, and enthusiastic Drug Product Development & Manufacturing individual who is excited to support the company at a critical stage in its growth trajectory. You...Work at officeLocal areaRemote work1 day per weekEntrada Therapeutics
Boston, MA4 days ago- ...Principal Mechanical Engineer Saab Inc., Autonomous and Undersea Systems division is seeking an innovative... ..., understanding, and implementing product design requirements for autonomous... ...for access to classified information. Drug-Free Workplaces: Saab is a federal government...Temporary workFor contractorsWork experience placementFor subcontractorCasual workLocal areaRemote work
SAAB
Quincy, MA1 day ago $179k - $254.3k
...the largest service providers. We move with precision and vitality, relying on strong cross-functional partnerships across product, engineering, sales, customer success, legal, finance, and operations to achieve business outcomes.We operate with a strong ownership attitude...Full timeContract workTemporary workLocal areaRemote workFlexible hoursCISCO Systems
Boston, MA1 day ago- ...Job Description Job Description Drug discovery is broken. We're building the AI that... ...and operator to join our technical and product founders. As Co-founder & CEO you take... ...place biology gives a straight answer. An engine validated against that benchmark is more...Full timeImmediate startFlexible hours
Deep Science Ventures
Boston, MA17 days ago $102.3k - $209.5k
...opportunity to drive real transformation. This Product Marketing and GTM Leader will: Unlock... ...conduit between inbound product teams, engineering, marketing, sales and the customer.... .../occupational health mandates, and/or drug testing requirements. Range and benefit...Temporary workRelocation packageFlexible hoursOracle
Boston, MA2 days ago$114.6k - $234.6k
...Description We are seeking a skilled engineer or scientist to lead the deployment and... ...the qualification, integration, and mass production of liquid cooling systems at external manufacturing... .../occupational health mandates, and/or drug testing requirements. Range and...Temporary workFlexible hoursOracle
Boston, MA2 days ago$240k - $305k
...highly collaborative Executive Director, Product Quality to serve as the Company's senior... ...Director will serve as the SVP's principal operational partner in the development and... ...Provide senior Quality oversight across CMC, drug substance and drug product manufacturing,...Contract workTemporary workAura Biosciences
Brighton, MA2 days ago$176.2k - $277.3k
...seeking a Discovery Program Leader (DPL) to represent Nonclinical Drug Safety (NDS) on discovery research teams and in scientific and... ...development teams, informing on preclinical studies to support product development. Qualifications, skills and experience needed: PhD in...Full timeFor contractorsLocal areaWorldwideFlexible hoursMerck Sharp & Dohme (MSD)
Boston, MA4 days ago$160k - $240k
...for the technical execution of biologics drug substance manufacturing at external... ..., ensuring rapid containment to protect product quality and supplyLead cross-functional... ...degree in Biological Sciences, Chemical Engineering, Chemistry or related discipline; advanced...Full timeSummer workRemote workFlexible hoursShift work2 days per weekVertex Pharmaceuticals
Boston, MA15 hours ago- Production Support And IT Operations LeadLocation: Canton, MAJob DescriptionMust Have Technical/Functional SkillsExperience in production support / IT operations / service delivery in healthcare domain.Deep understanding of ITIL processes (Incident, Problem, Change, Release...
$265.51k - $280k
...Qualifications Requires a Bachelor’s degree in Electrical Engineering, or a related Science, Engineering or Mathematics field. Also... ...engineering tasks.Collaborate with cross-functional teams to support product development and security analysis.Involved in Protocol...Remote workFlexible hoursGeneral Dynamics Mission Systems
Dedham, MA4 days ago$152k - $206k
...Principal Product Manager, Underwriting Specialist, CoStar Debt Solutions Job Description... ...should expose this” — working directly with engineering and product on where the line gets... ...Medical / Vision / Dental / Prescription Drug ~ Life, legal, and supplementary insurance...Hourly payImmediate startDay shift$131k - $159k
...Select, and Grassroots—offer premium products and services in both medical and... ...shape the future of cannabis. Title: Principal MEP and Facilities Engineer Location: Remote / Field : You... ...Individuals adversely impacted by the war on drugs are encouraged to apply....Permanent employmentFull timeFor contractorsRemote workCuraleaf
Boston, MA4 days ago$132.8k - $250.8k
...are looking for a customer-centric Mobile Engineering Manager who embraces lean and agile... ...partnering directly and continuously with product owners, designers, and engineering leaders... ..., dental, vision and prescription drug coverage • Flexible family care days,...Immediate startRemote workFlexible hoursFord Motor Company
Boston, MA1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Principal Engineer, Drug Product. Be the first to apply!
Related searches
- general engineer Norwood, MA
- data center chief engineer Norwood, MA
- chief engineer Norwood, MA
- principal engineer Norwood, MA
- engineering director Norwood, MA
- hotel chief engineer Norwood, MA
- principal developer Norwood, MA
- principal Norwood, MA
- senior principal scientist Norwood, MA
- civil engineer project manager