Senior Equipment Engineer

The Fountain Group LLC

Fremont, CA

JOB DETAILS
SALARY
SKILLS
Automation, CIP (Clean-in-Place), Capacity Utilization, Capital Expenditure (CAPEX), Centrifuge, Change Control, Column Chromatography, Commissioning, Consulting, Continuous Improvement, Corrective and Preventative Action (CAPA) Systems, Drug Products, Environmental Design, Feasibility Analysis, GMP (Good Manufacturing Practices), Identify Issues, Manufacturing, Operational Expenditure (OPEX), People Management, Professional Engineer, Project Commissioning, Project Estimates, Project Execution, Project Planning, Project Start-Up, Project Tracking, Project/Program Management, Risk Analysis, Root Cause Analysis, SIP (Sterilization-in-Place), Standard Operating Procedures (SOP), Startup, Structural Evaluation, Systems Analysis, Team Lead/Manager, Technical Analysis, Technical Leadership, Technology Analysis, Value Engineering
LOCATION
Fremont, CA
POSTED
25 days ago
Pay: $100.67/Hour

Duration: 6+ Months

Duties:

  • The Senior Engineer, Equipment is the Engineering technical lead on the Bulk Drug Substance (BDS), Drug Product (DP) and/or Process Science (PS) systems.
  • This includes but is not limited to Upstream and Downstream BDS, Filling and Packaging equipment.
  • Serve as a primary consultant to troubleshoot equipment/process issues through initial qualification and system release, support/participate/lead site CAPEX/OPEX/continuous improvement projects from feasibility study to handover.
  • Might also own change control and participate in deviation/risk assessment activities.
  • Manage medium in size and complexity equipment related projects.
  • Expected to act as System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.
 
Technical Expertise
  • Experience and knowledge with process systems and equipment within the following areas: Bioreactors, Centrifuges, Chromatography skids and Columns, Prep and Hold tanks, CIP/SIP, Filling and Packaging equipment
  • Uses expert knowledge about the processes, automation and process-specific technology to participate in troubleshooting as the Engineering technical lead.
  • Technical Analysis: including process system and technology plant fits, capacity and equipment utilization, value engineering, sustainable design, constructability and assessment of applicable new technologies to balance performance, cost and maintainability.
 
Project Management
  • Lead/participate in CAPEX/OPEX/CI projects
  • Own risk assessment for new systems and changes to existing systems
  • Write/review project execution plans
  • Lead/manage startup/commissioning activities (e.g. approve commissioning report, review/approve TOPs, create/update/review/approve SOPs...)
  • Technical approvers of protocols and periodic monitoring
  • Lead/manage project team including overseeing & providing guidance on contractors' activities
  • Provides estimates of resource requirements
 
 Qualifications:
  • Minimum of 4 years' working experience in a GMP manufacturing environment
  • Minimum 5 years and hands on experience with process system/equipment
  • Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.
  • Expert on troubleshooting technical issues
  • Owner of change control, deviation and CAPA
  • Capable to lead projects (CAPEX or CI)
  • Oversee contractor(s) and provide guidance/approval on activities at site
  • Bachelor’s in Engineering, 5-10 years of related field experience or Master’s in Engineering, +5 years’ of related field experience or P.E. License

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About the Company

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The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/