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Engineer II, Manufacturing Sciences
2 months ago
The Manufacturing Sciences & Technology (MS&T) team plays a critical role in the successful transfer of technology and provision of technical support for our plasmid and custom nucleotide platforms in the context of clinical and commercial drug substance cGMP manufacturing.
As an Engineer II within MS&T, you will collaborate closely with various stakeholders including Process Development, Manufacturing Operations, Regulatory Affairs, and Quality Assurance to ensure the effective execution of technology transfer and technical support initiatives. Your engineering expertise will be essential in supporting the process equipment utilized in our cGMP manufacturing facilities.
Key Responsibilities- Adhere to all relevant GMP regulations, guidelines, and internal policies to maintain compliance with regulatory standards.
- Promote and practice safe working habits, following established safety procedures.
- Execute tasks as outlined in internal guiding documents, including standard operating procedures (SOPs) and work instructions.
- Maintain Good Documentation Practices and Data Integrity to ensure that data and records are accurate and available for audits.
- Utilize various manufacturing support systems and equipment as necessary, including SAP, VEEVA, Delta V, Syncade, LIMS, and CMMS.
- Support technology transfer projects by coordinating process information exchange, documenting process parameters, and monitoring process performance.
- Provide basic technical support for cGMP manufacturing, including the creation of simple technology transfer documents and participation in validation activities.
- Analyze manufacturing performance through data review and establish data repositories.
- Collaborate with process development teams to investigate root causes of deviations.
- Lead cross-functional teams in troubleshooting and operational improvements for manufacturing equipment.
- Design and engineer basic disposable systems for bioprocessing, including aseptic bioprocessing bags and tubing manifolds.
- Author and execute protocols that support process characterization and equipment scaling in cGMP manufacturing.
- Occasionally provide weekend or evening support for Manufacturing Operations.
- Authorize forward processing and assess impacts for deviations, subject to Quality review.
- Perform additional duties as assigned.
Minimum Education: Bachelor's Degree
Minimum Experience: Bachelor's Degree (STEM Preferred) with 3-5 years of industry experience or a Master's Degree with 1-2 years of industry experience.
Preferred Qualifications- Understanding of GMP regulations.
- Experience in bioprocessing unit operations such as fermentation, enzymatic reactions, chromatography, or tangential flow filtration.
- Knowledge of data management and statistical analysis.
- Strong judgment and communication skills to articulate manufacturing issues effectively.
- Excellent verbal and written communication abilities.
- Capability to manage projects and adapt in a dynamic environment.
- A collaborative spirit in a cross-functional setting.
- A passion for contributing to a high-growth, transformational company.
Since its inception, Moderna has aimed to establish a leading mRNA technology platform and a world-class team dedicated to revolutionizing medicine. We are committed to fostering a culture of belonging and building an organization that prioritizes the well-being of our patients, employees, and communities.
Moderna values in-office collaboration and embraces a 70/30 work model to enhance innovation, teamwork, and mentorship. Join us in our mission to make a meaningful impact in the field of medicine.
Moderna is an equal opportunity employer and is committed to diversity and inclusion in the workplace.
