Process Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500 employees globally, with over 30 locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

Job Description:

Job Title: Process Engineer

Location: Bothell, WA 98021 (100% Onsite)

Duration: 12 Months (Extendable)

Pay Rate: $55.00 - 60.67/hr on W2

Top Skills-

Manufacturing process experience

Tagging EBR parameters

Data analytics

Data enablement

Data verification

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’s GMP 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

Awards and Accolades:

America's Most Honored Businesses (Top 10%)

Awarded by USPAAC for the Fastest Growing Business in the US

12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)

Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)

Top 100 by Dallas Business Journal (2020 and 2019)

Proven Supplier of the Year by Workforce Logiq (2020 and 2019)

2019 Spirit of Alliance Award by Agile1

2018 Best of the Best Platinum Award by Agile1

2018 TechServe Alliance Excellence Awards Winner

2017 Best of the Best Gold Award by Agile1(Act1 Group)