JOB SUMMARY

Responsible mid-level engineer to support site engineering and technical disciplines that support gene therapy processes which encompass facilities, maintenance, capital projects, validation, and EHS. The right individual for this position must be able to work independently and as a group contributor. This individual must be able to change directions in a fast-paced environment. This person will be responsible for project management, CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization and ensuring all project and day-to-day activities are performed and compliant to all site EHS policies and procedures while maintaining accuracy and quality from conception to completion.

ESSENTIAL JOB FUNCTIONS

• Prepare, schedule, coordinate and monitor their assigned engineering projects
• Monitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications
• Interact daily with internal team member and external third parties to interpret their needs and requirements and represent them in the field
• Perform overall quality control of their work (budget, schedule, plans, personnel performance) and report regularly on project and maintenance/calibration status
• Cooperate and communicate effectively with team members, other project participants, and upper management to assist with technical support
• Execute, development/implementation/ maintenance of environmental and safety management systems
• Coordinates the day-to-day implementation of the site safety and environmental policies and procedures
• Develops and conducts periodic safety audits / assessments to evaluate compliance to facility safety & environmental policies & procedures
• Troubleshoots equipment and systems issues and develops solutions
• Ensure internal and external team members/contractors maintain the highest quality standards
• Identifying deficiencies in MEP processes and developing improvements
• Developing, initiating, and managing all phases of projects, maintenance/calibration, and EHS
• Preparing documentation of critical analysis and providing suggestions for correcting errors across projects, maintenance/calibration, and EHS

SPECIAL WORK REQUIREMENTS

• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

EDUCATION/CERTIFCATIONS/LICENSES

ON-THE-JOB EXPERIENCE

SKILLS/ABILITIES

Work Environment

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
• Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
• Occasionally exposed to extremely loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning, and qualification) is required

Movement

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms 
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 10 pounds
• Occasionally lift and/or move up to 25 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail