MSAT Process Engineer

JOB TITLE: Senior Specialist - MSAT Process Engineering

Location: Bothell, WA (100% onsite)

Duration: 9 months initial (potential extension/potential right to hire)

Work Hours- M-F; Standard Hours

Position Summary

The primary focus of the Senior Specialist - MSAT Process Engineering is to provide support to the implementation of impactful projects that drive continued process verification and process monitoring at Client facility in Bothell, WA.

- Experience in process operations and support, including batch record review (cell therapy process experience preferred)

- Provides support for data extraction and verification to enable the implementation of an automated tool for CPV and process monitoring

- Cross-functional collaboration required between site MSAT, IT, vendors and global team, and partnership with Project Management to integrate all technical deliverables within a single comprehensive project plan to ensure successful implementation of capital projects

- Gather functional requirements and architect end-to-end solutions for scaling analytical capabilities

- Supports routine process monitoring for drug products currently manufactured at the Bothell facility, to help identify process improvement and opportunities to gain efficiency

- Makes data driven decisions and recommendations

- Leads MSAT driven cross-functional and cross-site projects

- Routinely collaborates with global teams, other CTDO sites and vendors

Key Responsibilities

- Functions as a technology, product, and process subject matter expert; may serve as system SME on one or more manufacturing unit operations

- Drive and support the implementation and deployment of an automated CPV and process monitoring tool aligned with Quality System and business requirements

- Execute data driven initiatives that enhance quality, improve operational efficiency, support local and global reporting, and strengthen data handling processes.

- Lead or assist in designing, testing, and deploying manufacturing analytics solutions

- Translate business and process requirements into functional and design specifications to support system configuration and implementation

- Perform process monitoring activities, including collecting, organizing and evaluating data to support CPV

- Analyze trends of clinical and commercial production data to drive actions for manufacturing process improvement

- Apply continuous improvement/lean tools to identify opportunities for process improvements and operational efficiencies, and drive cross-functional projects to implement

- Communicate insights, risks, and recommendations to cross-functional stakeholders in clear, concise, actionable formats.

Qualifications & Experience

Specific Knowledge, Skills, Abilities:

• Demonstrated problem-solving skills with the ability to independently troubleshoot and resolve complex process challenges

• Demonstrated ability to effectively work in and lead cross functional teams, meet deadlines, and prioritize multiple projects

• Able to apply engineering principles and statistical analysis to resolve processing issues and evaluate process improvement opportunities

• Demonstrated scientific and technical acumen including technical writing skills

• Education/Experience/ Licenses/Certifications:

• BS and/or MS degree in chemical or bioprocess engineering, biotechnology, biosciences, or a related field

• Immunology education preferred

• 3 years relevant experience in biologics or cell therapy manufacturing or development with BS, or 2 years relevant experience with MS

• Preferred experience: cGMP, Lean/six sigma

If hired, you will enjoy the following Eclaro Benefits:

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro

If you feel you are qualified with the required skills and if you are interested, please free to send your word version most updated resume TAILORED to the job description above to June@eclaro.com or call (212)804-7476.

Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.