Apply on Employer Site

Moderna · 5 days ago

Principal Engineer, Drug Product, Global Engineering

Norwood, MA

Full-time

Onsite

Senior Level, Lead/Staff

$138K/yr - $248K/yr

8+ years exp

Moderna is a leading mRNA technology company aiming to revolutionize medicine. The Principal Engineer, Drug Product, will lead the design, development, and validation of drug product manufacturing processes, ensuring compliance with quality and safety standards while collaborating with cross-functional teams and mentoring junior engineers.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

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

Qualification

Aseptic processingGMP knowledgeProcess validationProject managementTechnical documentationProblem-solvingAnalytical skillsStatistical analysisInterpersonal skillsCommunication skillsMentoringCollaborationTechnical leadership

Required

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 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