Principal Engineer, Drug Product, Global Engineering
4 days ago
We are seeking a highly skilled Principal Engineer, Drug Product, Global Engineering to lead the design, development, and validation of drug product manufacturing process equipment and facilities throughout our global footprint. The successful candidate will have extensive experience in aseptic processing and sterile manufacturing, with a proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes.
Key Responsibilities- Lead the design and development of aseptic manufacturing processes for drug product facilities.
- Lead Front End Planning (FEP) activities for the fill finish equipment scope on capital projects and programs.
- Lead equipment vendor selection and assessments.
- Develop user requirements, design specifications, process parameters, and FMEA assessments.
- Develop and maintain contamination control strategies to prevent microbial contamination.
- Ensure all aseptic operations adhere to Good Manufacturing Practices (GMP) and other relevant guidelines.
- Lead strategies for aseptic process commissioning, qualification, and support Media Fills and process validation, support protocols development in compliance with regulatory requirements (e.g., FDA, EMA).
- Prepare and review technical documentation, including validation reports, standard operating procedures (SOPs), and regulatory submissions.
- Serve as a Subject Matter Expert and work closely with Manufacturing and other functional groups to implement and scale up aseptic processes.
- Provide technical leadership and guidance to junior engineers and others in equipment design, problem-solving efforts, and troubleshoot aseptic process issues.
- Identify new technologies in aseptic processing and sterile manufacturing technologies.
- Drive results by owning deliverables and assuring on-time milestones completion in capital projects.
- Mentor and train team members on best practices in aseptic operations.
- Ph.D. in Chemical Engineering, Mechanical, or a related field with 8+ years of relevant experience, or
- M.S. with 10+ years of relevant experience, or
- B.S. with 12+ years of relevant experience.
- Extensive experience in aseptic processing and sterile manufacturing.
- Proven track record of successful commissioning, qualification, validation, and commercialization of aseptic processes.
- Strong knowledge of GMP, ICH guidelines, and regulatory requirements for aseptic operations.
- Experience with various aseptic techniques and equipment (e.g., isolators, cleanrooms, sterilization methods).
- Excellent problem-solving and analytical skills.
- Strong project management and organizational abilities.
- Effective communication and interpersonal skills.
- Ability to work collaboratively in a cross-functional team environment.
- Proficiency in using aseptic process development and validation tools.
- Experience in large capital/expansion programs with direct design responsibility.
- Expected to be able to present own work to peers and cross-functional managers and influence decisions.
- Must be able to use technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions for complex problems.
- Proficient with Excel, Word, and PowerPoint are required and basic statistical analysis techniques are preferred.
- Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from supervisor.
- Ability to represent Moderna's mindsets, objectives, and policies in a professional and responsible manner.
-
Norwood, Massachusetts, United States BioSpace, Inc. Full timeJob OverviewThe Principal Engineer, Drug Product, will lead the design, development, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint. This role involves cross-functional collaboration with R&D, Quality, Regulatory, and Manufacturing teams to ensure that drug products meet quality, safety,...
-
Norwood, Massachusetts, United States Moderna Full timeAbout the RoleWe are seeking a highly skilled and experienced Principal Engineer to lead the design, development, and validation of drug product manufacturing process equipment and facilities throughout Moderna's global footprint.The successful candidate will be responsible for leading cross-functional collaboration with R&D, Quality, Regulatory, and...
-
Senior Automation Engineer
7 days ago
Norwood, Massachusetts, United States Moderna Full timeJob SummaryWe are seeking a highly skilled Senior Automation Engineer to join our team at Moderna. As a key member of our operations team, you will be responsible for designing, developing, and maintaining automation systems for our drug product equipment. Your expertise will ensure seamless and efficient manufacturing operations, while adhering to current...
-
Senior Director of Drug Product Development
4 weeks ago
Norwood, Massachusetts, United States Moderna Full timeAbout the RoleWe are seeking an experienced leader to join our Drug Product Development team at Moderna. As a key member of our organization, you will be responsible for driving the development and commercialization of our mRNA-based products.Key ResponsibilitiesLead and develop a team of scientists and engineers to advance our drug product...
-
Senior Automation Engineer
3 weeks ago
Norwood, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Senior Automation Engineer to join our team in the Drug Product Equipment Support department. As a key member of our team, you will be responsible for designing, developing, and implementing automation systems for our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility.Key ResponsibilitiesDesign...
-
Senior Automation Engineer
2 weeks ago
Norwood, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Senior Automation Engineer to join our team in the Drug Product Equipment Support department. As a key member of our team, you will be responsible for designing, developing, and implementing automation systems for our state-of-the-art Drug Product (Fill Finish) cGMP manufacturing facility.Key ResponsibilitiesDesign...
-
Senior Drug Product Development Manager
2 weeks ago
Norwood, Massachusetts, United States Moderna Full timeAbout the RoleModerna's Drug Product Development team is seeking an experienced, innovative, and accomplished leader to join our team. As a Senior Drug Product Development Manager, you will be responsible for leading the development of and execution of drug product strategy, contributing to program leadership, staff development, and growth of the...
-
Senior Automation Engineer
3 weeks ago
Norwood, Massachusetts, United States Moderna Full timeJob SummaryWe are seeking a highly skilled Senior Automation Engineer to join our team at Moderna. As a key member of our automation team, you will be responsible for designing, developing, and implementing automation systems for our drug product equipment. Your expertise will ensure seamless and efficient manufacturing operations, while adhering to current...
-
Senior Engineer, mRNA Technology
3 weeks ago
Norwood, Massachusetts, United States Moderna Full timeAbout the RoleWe are seeking an experienced and accomplished leader to join our Drug Product Development team at Moderna. As a Principal Engineer, you will play a critical role in ensuring the translation of mRNA technology into successful dosage forms and commercial products from a pharmaceutical sciences and engineering perspective.Key...
-
Principal Electrical Engineer
2 weeks ago
Norwood, Massachusetts, United States GCR Professional Services Full timePrincipal Electrical EngineerGCR Professional Services is seeking a highly skilled Principal Electrical Engineer to join our team.Key Responsibilities:Design and develop high-voltage electrical systems, including power supply topologies such as H-Bridge, Flyback, Resonant, Buck, and Boost.Conduct thorough analysis and testing to ensure system reliability and...
-
Senior Engineer, mRNA Technology
3 weeks ago
Norwood, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced and accomplished leader to join our Drug Product Development team as a Principal Engineer. In this role, you will contribute to the development and execution of drug product strategy, lead matrixed teams, and advance Moderna's mRNA pipeline and technology platforms.Key ResponsibilitiesLead, develop, and inspire a team...
-
Senior Director of Drug Product Development
3 weeks ago
Norwood, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced and accomplished leader to join our Drug Product Development team as a Senior Director of Drug Product Development. In this role, you will be responsible for leading the development of and execution of drug product strategy, contributing to program leadership, staff development, and growth of the organization.Key...
-
Electrical Systems Engineer
4 weeks ago
Norwood, Massachusetts, United States GCR Professional Services Full timePrincipal Electrical EngineerBackground Check and Drug Test RequiredAs a hands-on Principal Electrical Engineer at GCR Professional Services, you will be responsible for designing and implementing various power supply topologies, including H-Bridge, Flyback, Resonant, Buck, and Boost.Key Responsibilities:* Develop and maintain a deep understanding of power...
-
FM Approvals Engineer
7 days ago
Norwood, Massachusetts, United States FM Global Full timeAbout the RoleFM Global is seeking a highly skilled Materials Engineer to join our team in the FM Approvals department. As a Materials Engineer, you will play a critical role in the evaluation and certification of property loss prevention products, with a focus on building materials and assemblies.Key ResponsibilitiesPlan, conduct, and direct the evaluation...
-
FM Approvals Engineer
3 weeks ago
Norwood, Massachusetts, United States FM Global Full timeAbout the RoleFM Approvals is a leading provider of third-party testing and certification services for property loss prevention products. We are seeking a skilled Materials Engineer to join our team and contribute to the evaluation and certification of building materials and assemblies.Key ResponsibilitiesPlan, conduct, and direct the evaluation and...
-
Norwood, Massachusetts, United States FM Global Full time{"title": "Explosion Protection Research Scientist", "subtitle": "Join FM Global's dynamic team of researchers and engineers", "content": "FM Global is a leading property insurer of the world's largest businesses, providing more than one-third of FORTUNE 1000-size companies with engineering-based risk management and property insurance solutions.The purpose...
-
Senior Aseptic Process Engineer
3 weeks ago
Norwood, Massachusetts, United States Moderna Full timeAbout the RoleWe are seeking a highly skilled Senior Aseptic Process Engineer to lead the design, development, and validation of drug product manufacturing process equipment and facilities at Moderna. As a key member of our Global Engineering team, you will be responsible for ensuring the timely and accurate delivery of projects, collaborating with...
-
Research Engineer
3 weeks ago
Norwood, Massachusetts, United States FM Global Full timeJob SummaryTo plan, conduct, and direct the development and evaluation of scientific and engineering projects in electrical engineering, with minimal supervision, to increase technical knowledge and provide solutions.Key ResponsibilitiesDevelop or direct the evaluation of engineering solutions, new engineering technologies, or scientific knowledge in...
-
Senior Aseptic Process Engineer
4 weeks ago
Norwood, Massachusetts, United States BioSpace, Inc. Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Aseptic Process Engineer to lead the design, development, and validation of aseptic manufacturing processes for drug product facilities. As a key member of our Global Engineering team, you will be responsible for ensuring that all aseptic operations adhere to Good Manufacturing Practices...
-
Process Engineer
7 days ago
Norwood, Massachusetts, United States Connexion Systems & Engineering, Inc. Full timeJob Title: Sr. Engineer I – Engineering ProjectsLocation: Norwood, MA – on-sitePay: $70-80/hourThe Role:The Process Engineer will serve as a Technical Lead for Capital projects, overseeing GMP manufacturing process equipment at the manufacturing facility in Norwood, MA. This individual will collaborate closely with MS&T, Facilities, Validation, and...
