Project Engineer - new job in Fishers, US

Job Title: Project Engineer
Job Type: Permanent Full-Time
Location: Fishers, IN

We are searching for a full-time permanent Project Engineer to support site engineering and technical disciplines that support gene therapy processes in an organization that produces GMP viral vectors, and provides cell transduction for gene and cell therapy clinical trials.

This successful candidate 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.

WHAT YOU GET TO DO:

Responsibilities include, but are not limited to:

• 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

WHAT YOU HAVE:

• BS/BA degree in Engineering, Science, Technical or related field
• Previous Pharmaceutical, Biomedical, or Medical Device experience is required
• Must have 10+ years of proven working experience as an Engineer, Project Manager
  • the successful candidate must have experience in CQV, master planning. CAPEX/OPEX, change control, and continuous improvements/optimization
• PMP certification preferred
• Excellent knowledge of design and visualization software such as AutoCAD

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

SRG is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.