Principal Process Engineer

Principal Process Engineer at Brooksource Principal Process Engineer at Brooksource in Benet Lake, Wisconsin Posted in 2 days ago.

Type:

full-time

Job Description:

Principal Process Engineer -

Aseptic Vial Lines Location:

Kenosha, WI (Onsite)

Company:

Brooksource Engineering Services Position Overview Brooksource Engineering Services is seeking a Principal Process Engineer to provide senior-level, hands-on engineering leadership for aseptic vial filling and handling operations within a GMP sterile manufacturing environment. This role owns the technical performance of vial filling lines, focusing on equipment functionality, process control, and aseptic reliability through direct floor engagement. Key Responsibilities Act as the primary technical owner for aseptic vial filling and handling equipment. Provide hands-on floor support to resolve complex equipment and process issues impacting vial line performance. Lead troubleshooting of vial washers, depyrogenation tunnels, filling, stoppering, and capping systems. Drive technical investigations and implement equipment- and process-focused corrective actions. Ensure vial line operations remain compliant with aseptic processing and GMP requirements. Support execution of IQ/OQ/PQ and requalification activities for vial filling systems and changes. Partner cross-functionally to improve throughput, reduce interventions, and strengthen sterility assurance. Lead continuous improvement initiatives focused on vial handling, line efficiency, and defect reduction. Provide technical mentorship and guidance to engineers and technicians supporting vial operations. Qualifications Bachelor's degree in Engineering (Chemical, Mechanical, Industrial, or related discipline). Deep hands-on experience supporting aseptic vial filling operations in a sterile manufacturing environment. Strong preference for direct production support over qualification-only experience. Expertise in troubleshooting vial washers, depyrogenation tunnels, and aseptic filling equipment. Strong understanding of cGMPs, aseptic processing, and risk-based engineering principles. Experience with Optima or comparable vial filling platforms is a plus. Brooksource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks Benefits & Perks:

Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee's needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.