• Technical Expertise
• Experience ' knowledgeable with facilities within the following areas: site utilities system and equipment (i.e. WFI, CSG, Plant steam, HVAC, clean compressed gases, chiller, building generator and etc.), office and amenities, knowledge of commercial/clinical manufacturing and warehouse operations.
• Manage the life cycle management of the facilities/utilities equipment.
• Responsible for the economic and reliable availability and flexibility of their system.
• Expert knowledge of processes, automation and equipment-specific technology to lead in troubleshooting as the Engineering technical lead.
• Lead/manage technical analysis: including mechanical 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 CAPEX/OPEX/CI projects, including but not limited to:
  • 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 contractor 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.
• Own/execute CAPA, deviation, change control, and risk assessment (quality, business and/or safety)
• Global Engineering
• Supports 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.
• Others
• 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.
• Oversee contractor(s) and provide guidance/approval on activities at site
• Coach junior engineer(s)

Requirements

Sr Engineer Requirements:
Bachelors Degree from an accredited institution in Engineering with eight (8) years of related field experience, Or
Masters Degree from an accredited institution in Engineering with (6) years of related field experience, Or P.E. License
Minimum of four (4) years working experience in a GMP manufacturing environment
Minimum five (5) years and hands on experience with utilities system/equipment

Engineer Requirements:
Bachelors Degree from an accredited institution in Engineering with three (3) years of related field experience

Knowledge of GMP compliance
Technical expertise on utility equipment/system
Recognize safety requirements in manufacturing environment
Equipment hands on experience
Project leadership experience
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
Owner of change control, deviation and CAPA
Capable to lead projects (CAPEX or CI)
Physical demands/surroundings - works primarily in an office environment. it is 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.

Eligibility Requirements:
Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.