Tolmar · 13 hours ago
Process Development Engineer II - Manufacturing (1st, 2nd or 3rd Shift)
Windsor, CO
Full-time
Onsite
Mid Level
$88K/yr - $95K/yr
3+ years expTolmar is a company focused on aseptic manufacturing operations, and they are seeking a Process Development Engineer II to provide technical leadership in ensuring robust and compliant processes. The engineer will monitor critical process parameters, lead technical investigations, and partner with various teams to implement process improvements.
BiotechnologyHealth CareManufacturing
Responsibilities
Serve as the primary technical engineering resource on the manufacturing floor during aseptic bulking, cleaning, milling, and filling activities
Actively monitor and verify critical operational steps, environmental controls, and in‑process parameters to ensure compliance with cGMP and aseptic best practices
Provide real‑time decision support for process deviations, equipment malfunctions, and unexpected process conditions
Support manufacturing execution by ensuring processes consistently run within defined control limits and established batch record requirements
Lead or support complex root cause investigations, deviations, CAPAs, and change controls; write clear, technically sound, inspection‑ready reports
Use appropriate and approved tools to gather data and drive scientifically justified conclusions
Develop, revise, and optimize SOPs, Wis, batch records, and control documentation to strengthen process robustness and clarity
Conduct and support on‑floor studies and process verifications
Support cleaning validation, process validation, and ongoing process capability monitoring
Partner with Quality, Validation, and Engineering to ensure process changes and enhancements are technically justified and compliant
Lead and contribute to continuous improvement initiatives that improve yield, reduce variability, strengthen aseptic behaviors, and enhance equipment reliability
Assist in evaluating and implementing new technologies, process automation, analytics, and equipment enhancements to support commercial operation
Provide hands‑on training, technical coaching, and aseptic technique reinforcement for operators and supervisors
Support onboarding of new operators and engineers with a focus on sterile technique, process understanding, and technical problem‑solving
Act as a subject matter resource for internal audits, regulatory inspections, and cross‑functional technical discussions
Participate in hazardous waste, chemical handling, and spill response training; ensure compliance with all safety requirements
Perform additional responsibilities as assigned
Qualification
Required
Bachelor's degree in Chemical engineering or other scientific discipline required
Three or more years of experience in pharmaceutical/biotech process development, manufacturing, or MS&T support role
Two or more years of experience in aseptic operations
Strong knowledge of aseptic processing, sterile technique requirements, and pharmaceutical manufacturing systems
Demonstrated ability to monitor and troubleshoot aseptic operations and process performance issues
Strong analytical and problem‑solving skills, including use of statistical tools and experimental design
Excellent technical writing skills; able to produce clear, concise, and scientifically sound investigations and reports
Effective communicator with the ability to collaborate across manufacturing, quality, engineering, and development teams
High attention to detail, strong sense of personal accountability, and ability to excel in a fast‑paced environment with shifting priorities
Ability to work independently with minimal oversight and make sound technical decisions in real time
Ability to analyze complex development problems and provide creative solutions
Benefits
Bonus Eligible
Shift differentials: 2nd shift - 8%, 3rd shift - 10%
Benefits information: https://www.tolmar.com/careers/employee-benefits
Company
Tolmar
TOLMAR is a northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company.
1001-5000 employees
H1B Sponsorship
Tolmar 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
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Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (5)
2022 (3)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
A
Anil D'souza
Chief Executive Officer
Gerald Wallner
Data Integrity Manager
Recent News
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