Aseptic Process Engineer

PSC Biotech•Manchester, NH

About The Position

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success. The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents. We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn. At PSC Biotech®, it’s about more than just a job—it’s about your career and your future. Your Role We are hiring an experienced Aseptic Process Engineer to join our team! The Aseptic Process Engineer is responsible for supporting, optimizing, and sustaining aseptic manufacturing processes within a regulated biotech environment. This role focuses on sterile fill‑finish operations and lyophilization, ensuring processes are robust, compliant, and scalable from clinical through commercial production. The engineer will collaborate cross‑functionally with Manufacturing, Quality, Validation, and Engineering teams to maintain operational excellence, support technology transfers, and drive continuous improvement across aseptic operations. Support day‑to‑day aseptic manufacturing operations, including aseptic fill‑finish lines and lyophilizers, for clinical and/or commercial drug product manufacturing. Lead or support process optimization, troubleshooting, and root cause investigations related to aseptic processing and lyophilization performance. Develop, review, and maintain technical documentation such as SOPs, batch records, protocols, and engineering reports in compliance with cGMP requirements. Participate in equipment selection, installation, commissioning, qualification, and lifecycle management for aseptic filling equipment and lyophilization systems. Support lyophilization cycle development, scale‑up, and transfer, including collaboration with formulation and development teams as needed. Partner with Quality and Validation to support media fills, smoke studies, process validations, and regulatory inspections. Provide technical oversight during technology transfer activities and new product introductions. Identify and implement continuous improvement initiatives to enhance process reliability, efficiency, and product quality. Ensure adherence to safety, contamination control, and data integrity standards within classified cleanroom environments. This is a 3-month temporary contract with the potential to extend.

Requirements

Bachelor’s degree in Engineering (Chemical, Mechanical, Biomedical, or related discipline) or a relevant scientific field.
3+ years of experience in aseptic manufacturing within the biotech, biopharmaceutical, pharmaceutical, or CDMO industry.
Hands‑on experience with aseptic fill‑finish operations (vials, syringes, or cartridges).
Working knowledge of lyophilizers, including cycle development, operation, and troubleshooting.
Strong understanding of cGMP, sterile manufacturing practices, and contamination control strategies.
Experience supporting equipment qualification, process validation, and deviation investigations.
Ability to work effectively in cross‑functional teams within a regulated manufacturing environment.
Strong technical writing, problem‑solving, and communication skills.
Comfortable working in cleanroom environments and supporting off‑shift or on‑floor manufacturing activities as needed.
Must be authorized to work in the U.S.
No C2C at this time.

Responsibilities

Support day‑to‑day aseptic manufacturing operations, including aseptic fill‑finish lines and lyophilizers, for clinical and/or commercial drug product manufacturing.
Lead or support process optimization, troubleshooting, and root cause investigations related to aseptic processing and lyophilization performance.
Develop, review, and maintain technical documentation such as SOPs, batch records, protocols, and engineering reports in compliance with cGMP requirements.
Participate in equipment selection, installation, commissioning, qualification, and lifecycle management for aseptic filling equipment and lyophilization systems.
Support lyophilization cycle development, scale‑up, and transfer, including collaboration with formulation and development teams as needed.
Partner with Quality and Validation to support media fills, smoke studies, process validations, and regulatory inspections.
Provide technical oversight during technology transfer activities and new product introductions.
Identify and implement continuous improvement initiatives to enhance process reliability, efficiency, and product quality.
Ensure adherence to safety, contamination control, and data integrity standards within classified cleanroom environments.