Process Engineer 2

Work Location: Madison, Wisconsin
Shift: No
Department: LS-SC-POWTB Madison & Verona Tech Transfer
Hiring Manager: Jason Modest

This information is for internals only. Please do not share outside of the organization.

Your Role:

The process engineer is responsible for developing the manufacturing process train for custom products in GMP manufacturing and supporting the implementation of new manufacturing equipment. This role will collaborate with Manufacturing, Process Development, and Engineering to determine process needs and requirements for transferring production processes into the GMP space.

• Assesses facility fit, equipment needs, and manufacturing capabilities for new products.
• Collaborates with the Technical Transfer Scientist on process requirements for GMP transitions.
• Creates detailed process overviews and flow diagrams.
• Identifies and orders equipment for GMP manufacturing.
• Research new equipment and technologies for continuous improvement and capacity expansion.
• Establishes specifications for manufacturing equipment.
• Generates and approves procedures for equipment qualification and GMP operations.
• Initiates and reviews equipment change requests.
• Supports troubleshooting, systems improvement projects, and training for manufacturing equipment operation.

Who You Are

Minimum Qualifications:

• Bachelor's in Chemical and Mechanical Engineering, Chemistry, Biochemistry, or related Life Science discipline.
• 5+ years' experience in GMP Operations or a related field.

Preferred Qualifications:

• Comprehensive technical knowledge and understanding of GMP manufacturing equipment.
• Excellent attention to detail and the ability to effectively manage multiple projects.
• Effective communication and engagement skills (verbal, written, listening) with the ability to work with internal departments and customers.
• Ability to build a culture of trust and business-driven innovation; work with internal organizations to solve ongoing issues within the team.
• Ability to communicate and lend guidance on day-to-day workflow and overcoming challenges related to completing projects.
• Experience in API manufacturing.
• Experience in production with fixed equipment of 200 L or larger.
• Experience in handling High-Potency APIs is a plus.
• Experience with scaling processes from gram quantities to multi-kilogram quantities.
• Strong scientific problem-solving skills, including the ability to identify critical issues in experimental work and suggest possible solutions.
• Knowledge and understanding of the overall goals, implementation, and application of cGMP and other relevant quality systems.
• Superior organizational skills and the ability to multi-task proficiently.
• Excellent communication skills, including the ability to give presentations and speak to large groups, as well as establish rapport with non-technical parts of the company.
• Proficient in the use of standard office computers and software for laboratory work (data capture, data analysis, etc.) and statistical analysis, specifically MS Office 365, MS Project, ChemOffice, etc.

Pay Range for this position: $74,500-$121,700

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.