Lead Process Engineer

The businesses of Merck KGaA, Darmstadt, Germany•Madison, WI

About The Position

For over 25 years, Mirus Bio pioneered the manufacture of transfection reagents and proprietary technologies for nucleic acid delivery applications. Despite our extensive experience, we pride ourselves on maintaining the spirit of a startup. Our dynamic and forward-thinking approach has allowed us to stay agile and adapt to emerging trends. Our work is technical and cutting-edge, and we promote a culture that encourages creativity, initiative, responsibility, and respect. Our team members are engaged and motivated by the desire to support our customers to practice good science to generate strong results. Mirus, together with MilliporeSigma, is establishing the future of science and medicine by developing products that enable researchers within the cell and gene therapy space. Mirus Bio is seeking a Lead Process Engineer to support formulation/fill/finish processes and product packaging for Mirus Bio’s product portfolio including in vitro transfection reagents, nucleic acid labeling reagents, and accessory products. This individual contributor position will take key role on our Technology Transfer Core Teams and will drive process improvements to our existing portfolio. This role will work internally with our RUO Production Team and with our manufacturing partners. This role is a part of a dynamic and fast-paced environment that collaborates closely with Production, Quality, Product Management, Project Management, and R&D Departments in a small start-up style environment.

Requirements

Bachelor’s Degree in Engineering, or related discipline.
At least 5 years of engineering experience.
At least 4 years of experience with liquid formulation/fill/finish processes and/or life sciences/pharmaceutical packaging, or similar.
At least 2 years under the oversight of a Quality Management System.
Ability to work productively in a team environment including influencing actions and driving results.
Ability to work in a laboratory setting and lift 35 lbs. occasionally. Repetitive motion may be a work environment stressor for this position.
Excellent verbal and written communication skills required.
Demonstrated ability to identify and solve complex technical problems.
Ability to travel independently 10% of the time, including overnight travel
Ability to drive a vehicle; Must have current and valid U.S. driver license

Nice To Haves

Previous experience working for a life sciences company and in a cGMP environment is preferred.

Responsibilities

Subject Matter Expert (SME) who is responsible for creating and implementing systematic approaches and processes surrounding Mirus Bio’s formulation/fill/finish processes and primary packaging for both our RUO and GMP Product Portfolio.
Core Project Team Member supporting formulation/fill/finish processes for new product introduction tech transfers including manufacturing partner process development support, in addition to supporting the existing Mirus Bio product portfolio. Expertise in cGMP manufacturing, sterile fill, filtering, validated cleaning practices, and preferably with experience with hazardous/flammable materials.
Process Engineer for Mirus Bio products supporting both our internal production team and our manufacturing partners. This includes being responsible for supporting the process development at our manufacturing partners, being the SME of formulation/fill/finish processes, and providing ongoing process oversight. Experienced with process comparability analysis, pFMEAs, job hazard identification, risk mitigation, and drafting technology transfer reports.
Engineer with extensive knowledge on primary product packaging such as bottles, media bags, films, etc. and deep understanding of critical process material compatibility. Familiarity with extractables and leachables testing, dangerous goods primary packaging requirements, leak and pressure testing, etc.
Mirus Bio expert responsible for collaborating with MilliporeSigma resources on process development and process validation to align processes with global practices.
Process Engineer owning, overseeing, and supporting multiple projects and other activities in parallel. Adapts to changing priorities and works cross-functionally to ensure on time deliverables and while ensuring a balanced workload.
Drives collaboration with Product Management on Voice of the Customer input on primary product packaging user requirements (ex. media bag configuration requirements)
Thought Leader, Trainer, and Mentor for the Mirus Bio Organization on technical aspects of primary packaging requirements and critical formulation/fill/finish process parameters.
Problem Solving leader and SME driving advanced troubleshooting and cross-functional resolution of problems and improvements for both RUO and GMP Production. This may include commissioning and onboarding of new equipment and associated processes, and reducing manual processes.
Solid foundation in production and quality documentation including updating existing documents and writing change controls as required.
Effective communicator working across multiple teams, such as R&D, Operations, Project Management, Quality, and Product Management, to ensure alignment.
Follow GDP and cGMP guidelines and ensure quality compliance.