Process Engineer

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, EHS and continuous improvement. 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. This individual will be a key player in driving improvements and developing improved system and process operational design and procedures through site efficiency initiatives.

ESSENTIAL JOB FUNCTIONS

• Prepare, schedule, coordinate and monitor their assigned engineering projects
• Manage projects associated with workflow optimization, mistake-proofing, and continuous improvement.
• Support change management processes to achieve desired business outcomes in a complex business environment.
• Monitor compliance to all applicable FDA and EU practices, QA/QC policies, performance standards and specifications.
• Interact daily with internal team members 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

KNOWLEDGE, SKILLS AND EXPERIENCE

• BS/BA degree in Engineering, Science, Technical or related field
• Pharmaceutical, Biomedical, or Medical Device experience
• 3+ years of engineering/project management experience
• Proven working experience as an Engineer, Project Manager with experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization
• Adherence to all local, state, and governmental safety standards
• Excellent knowledge of design and visualization software such as AutoCAD
• Familiarity with rules, regulations, best practices, and performance standards
• Advanced MS Office skills
• Decision making ability and leadership skills
• Time management and organization skills
• Ability to work with multiple discipline projects

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to work in a BSL 2 with personal protective equipment.
• While performing the duties of this job, the employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.  The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision, and ability to adjust focus. 
• In the performance of the duties of this job the employee is required to communicate using telephone and e-mail.
• While performing the duties of this job, the employee must be aware of potential exposure to moving mechanical parts; high, precarious places; toxic or caustic chemicals; high noise areas, and risk of electrical shock.
• A physically able individual is required who can spend time on the floor during activity execution (maintenance, construction, commissioning and qualification).