Senior Process Engineering Manager

SHARP STERILE MANUFACTURING LLC•Lee, MA

About The Position

The Senior Process Engineering Manager leads and oversees process engineering support for aseptic fill-finish and associated manufacturing operations at Sharp Sterile. This role is responsible for ensuring that critical process parameters (CPPs), product specifications, and regulatory requirements are consistently met across clinical and commercial parenteral drug product manufacturing. The position manages a team of process and operations-focused engineers who design, implement, and continuously improve filling processes, equipment change parts, and manufacturing solutions spanning vial washing through lyophilization and capping. The Senior Process Engineering Manager serves as a technical authority, people leader, and cross-functional bridge between Engineering, Manufacturing, Quality, Validation, Maintenance, Automation, and Clients. This role is hands-on, highly visible, and audit-facing, requiring continued qualification in filling operations and active participation in media fills and real-time process troubleshooting.

Requirements

5+ years in aseptic processing, terminal sterilization, or lyophilization
3+ years of people management or technical leadership experience
Strong understanding of parenteral drug product manufacturing
Expertise in process engineering principles and equipment lifecycle management
Proficiency in technical writing and quality documentation
Strong project management and cross-functional communication skills
Ability to operate effectively in a fast-paced, regulated environment
Ability to meet gowning requirements
Ability to stand or remain stationary for extended periods
Ability to lift up to 50 lbs occasionally
Adequate visual, auditory, and motor skills for equipment interaction

Nice To Haves

Advanced degree preferred (Master’s or higher in Engineering or related discipline)
Equivalent technical experience considered with demonstrated excellence
CAD / 3D modeling experience preferred

Responsibilities

Provide real-time technical support and issue resolution for aseptic filling operations.
Lead root cause investigations, deviations, and CAPAs related to process and equipment performance.
Oversee development, testing, and implementation of process improvements and engineered solutions.
Support continuous monitoring, troubleshooting, and optimization of filling operations.
Design, fabricate, and induct size/change part kits and process enhancements.
Lead process optimization initiatives aligned with business growth and capacity expansion.
Introduce new technologies and refine existing processes to improve efficiency, quality, and reliability.
Support process design, risk assessments, and technical readiness for tech transfers.
Collaborate on equipment and process validation (IQ/OQ/PQ) activities.
Ensure manufacturing processes meet regulatory and internal quality standards.
Serve as a technical SME for clients, auditors, and internal stakeholders.
Support regulatory inspections (FDA, EMA, client audits) and present technical content as needed.
Partner with Quality to develop and execute corrective and preventive actions.
Provide technical input to Sales for proposals and client discussions.
Support scheduling with realistic timelines for deliverables and manufacturing readiness.
Contribute budgetary guidance and ROI justification for capital and equipment investments.
Review and approve batch records, protocols, studies, and quality documentation.
Lead, mentor, and develop a team of process and operations engineers.
Set priorities, allocate resources, and balance project support with day-to-day manufacturing needs.
Partner with Manufacturing leadership to identify and execute process and equipment improvements.
Build organizational capability through recruiting, training, and professional development.
Promote a culture of ownership, compliance, and continuous improvement.
Ensure all activities comply with cGMPs and applicable regulatory requirements.
Maintain deep working knowledge of FDA, USP, EU Annex 1, and global regulatory standards.
Maintain qualification in aseptic filling operations, including successful media fill participation.