Engineering Line Lead

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and applications in cGMP settings.

• Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
• Drive technical improvements and internal/external responses to equipment and facility observations.
• Management of the assigned capital project schedules and budgets.
• Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
• Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
• Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
• Execute high level projects from conception, consistent with upper management objectives for business growth.
• Manage and execute facility and equipment updates to meet company growth and economic objectives.
• Support client audits and technical visits.
• Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have:

• Bachelors of Science in Engineering or related technical degree.
• 5+ years of Engineering Experience
• 3+ years of Engineering experience in the Bio Pharma industry
• 2+ years of Project Engineering/Management experience
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice to Have:

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Some Leadership,
  Supervisory experience over Jr. Engineers, Technicians.
• Experience with PM Software MS Project
  , Design software
  - AutoCAD & ERP SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Engineering Line Lead
• Spokane, Washington, United States