Sharp Sterile Manufacturing · 4 hours ago
Senior Process Engineering Manager
Lee, MA, US
Full-time
Onsite
Senior Level
$95K/yr - $150K/yr
5+ years expSharp Sterile Manufacturing is a company focused on aseptic fill-finish and associated manufacturing operations. The Senior Process Engineering Manager leads process engineering support, ensuring critical process parameters and regulatory requirements are met while managing a team of engineers to improve filling processes.
BiopharmaBiotechnologyHealth CareLife Science
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
Qualification
Required
5+ years in aseptic processing, terminal sterilization, or lyophilization
3+ years of people management or technical leadership experience
Equivalent technical experience considered with demonstrated excellence
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
Preferred
Advanced degree preferred (Master's or higher in Engineering or related discipline)
CAD / 3D modeling experience preferred
Company
Sharp Sterile Manufacturing
Sharp Sterile (formerly Berkshire Sterile Manufacturing) provides the safest sterile drug products for clinical use and small scale requirements through the use of modern technology, 100% isolator-based filling lines, and a skilled staff.
201-500 employees
H1B Sponsorship
Sharp Sterile Manufacturing has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (7)
2023 (6)
2022 (2)
2021 (2)
2020 (3)
Funding
Current Stage
Growth StageTotal Funding
$2MKey Investors
MassDevelopment
2023-10-05Acquired
2018-07-17Debt Financing· $2M
Recent News
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