Our client is a biotechnology company. They have asked us to assist them in a search for a Senior Engineer I, CMC Engineering.

Major tasks and responsibilities include:  

• Troubleshoots equipment systems and associated automation systems for production and utility equipment.
• Identifies and leads equipment related capital projects.
• Directs and supports the design, specification, and installation of new or modified equipment.
• Develops and supports equipment commissioning and validation activities.
• In collaboration with the Quality Assurance department, ensures that all activities are executed in compliance with regulatory guidelines.
• Develops preventative maintenance and calibration requirements for new equipment and instruments.
• Maintains personal training and goal development completion.
• Manages and provides direction to contractors.
• Ensures production equipment meets cGMP’s and are regulatory inspection ready.
• Supports investigations and associated CAPAs as required.
• Contributes to risk analysis and mitigation plans to ensure product quality.
• Works closely with cross-functional teams to meet production and project milestones.
• Utilizes project management tools such as schedules, action lists, and clear scope definitions to ensure the timely implementation of equipment improvements and compliance tasks.
• Regularly communicates with internal and external stakeholders including the presentation of initiatives to senior management.

We seek candidates with the following qualifications:  

• A Bachelor’s degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or equivalent is required.
• Must have a minimum of 4+ years of relevant pharmaceutical and biotechnology experience.
• Requires experience with sterile or aseptic processing equipment and GMP manufacturing.
• Experience supporting isolator technology and associated air handling equipment is preferred.
• Experience with contractor management is preferred.
• Ability to work on-site and periodic on-call availability is required.

If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms and Forbes' list of Top 200 Best Executive Recruiting Firms.