Production Associate – Filler

at Boehringer Ingelheim
Location Fremont, California
Date Posted August 1, 2022
Category Engineering
Job Type Full Time

Description

Description:

Engineer, Equipment or Senior Engineer, Equipment

Dual-Level posting, position level to be awarded at the discretion of the hiring manager.

Equipment Engineer Description:

The Equipment Engineer acts as an Engineering technical lead on Drug Product (DP). This includes but not limited to Upstream and Downstream BDS, Filling and Packaging equipment. Serve as a Primary Point of Contact 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. May also own change control and participate in deviation/risk assessment activities. Manage small in size and complexity equipment related projects. May be expected to act a System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Senior Equipment Engineer Description:

The Senior Engineer, Equipment is the Engineering technical lead on Drug Product (DP). This includes but 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 a System Owner for Process equipment (out of tolerance events, deviations, etc.) if required by area.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Equipment Engineer Duties & Responsibilities:

Technical expertise

  • Experience with process systems and equipment within the following areas: Filling and Packaging equipment. Knowledge about the processes, automation and equipment-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
  • Provide risk assessment for new systems and changes to existing systems
  • Write simple project execution plans
  • Execute startup/commissioning activities (e.g. write commissioning report, review/approve TOPs, create/update/review/approve SOPs...)
  • Technical reviews of protocols and periodic monitoring
  • Lead or participate in project team including the supervision of contractors
  • Provides estimates of resource requirements.

Optimization & Compliance

  • Contributes to the technical optimization of the field of care
  • Works with Senior Engineers to ensure the Process/Manufacturing equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards.
  • Contributes to and supports BPE/MPE activities to ensure a continuous optimization process.
  • Assist with CAPA, deviation, change control, and risk assessment (quality, business and/or safety) for activities up-to initial qualification/handover.

Global Engineering

  • Supports implementation and improvement of best practice of technical standards, procedures.
  • May participate in peer to peer reviews.

Senior Equipment Engineer Duties & Responsibilities:

Technical Expertise

  • Experience and knowledge with process systems and equipment within the following areas: 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, constructibility 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

Optimization & Compliance

  • Own technical optimization of the field of care. - Ensures that the facility equipment, machinery, documentation and technical support meets the compliance, quality and EHS standards. - Leads/motivates activities to ensure a continuous optimization process. - Leads/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety)

Global Engineering

  • Leads implementation and improvement of best practice of technical standards, procedures. - Acts as a member of Global Engineering Biopharmaceuticals and of global Engineering Boehringer Ingelheim. - Participates in peer to peer reviews.

Other

  • Creates curriculum and trains operations/facilities staff as required to ensure production/utilities commences at the desired rate. - Ability to manage vendors for the purposes of assessments and certifications. - Ability to independently make decisions. - Owner of change control, deviation and CAPA - Oversee contractor(s) and provide guidance/approval on activities at site - Coach junior engineer(s)

Equipment Engineer Requirements:

  • Bachelors degree from an accredited institution in Engineering plus five (5) years of related field experience, or Masters degree from an accredited institution in Engineering plus three (3) years of related field experience
  • Minimum of two (2) years working experience in a GMP manufacturing environment
  • Basic hands on experience with process system/equipment in DS and DP areas
  • Basic knowledge of commercial/clinical manufacturing and warehouse operations
  • Basic knowledge of risk assessment, root cause investigation, project startup/commissioning/qualification
  • Experience with troubleshooting technical issues
  • Understand compliance requirement on change control, deviation and CAPA
  • Basic knowledge in GMP manufacturing site
  • Basic knowledge of process equipment/system
  • Safety awareness in manufacturing environment
  • Basic equipment hands on experience
  • Physical demands/surroundings - works primarily in an office environment. Required to be on the process floor as necessary to perform work outlined in this profile. Some domestic and international travel may be required
  • Visual Demands - must be able to read and see clearly with or without correction lens
  • Attendance/schedule - attendance requirements are based on general attendance policies and the needs of the business as set forth by direct manager

Senior Equipment Engineer Requirements:

  • Bachelors degree from an accredited institution in Engineering, plus eight (8) years of related field experience; Or Masters degree from an accredited institution in Engineering, plus six (6) years of related field experience; Or P.E. License
  • Minimum of four (4) years of working experience in a GMP manufacturing environment
  • Minimum of five (5) years of hands on experience with process system/equipment
  • Excellent oral and written communication skills
  • Capable to own and lead risk assessment, root cause investigation, project startup/commissioning/qualification.
  • Expert on troubleshooting technical issues
  • Capable to lead projects (CAPEX or CI)
  • Knowledge of GMP compliance
  • ..... click apply for full job details

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