Engineering Manager

How you’ll make an impact:

Facilities at 2seventy bio includes 250,000SF of office, R&D lab, clinical manufacturing suites and commercial QC labs in Cambridge, along with 35,000SF of R&D/office space in Seattle.

This role is to provide 2seventy with engineering leadership and technical subject matter expertise across all engineering systems (both locations with a primary focus on Cambridge) to ensure business critical systems are designed, installed, qualified and maintained correctly delivering reliable operations for all 2seventy manufacturing and R&D activities.

The position will develop, improve and maintain all engineering guidelines, SOP’s, maintenance plans and other documentation to ensure 2seventy’s compliance with all regulatory standards for our growing GMP operations and R&D activities.

How you’ll spend your time:

• This role will serve as the Business & Technical System Owner for all Facilities Systems (Mechanical, Electrical, Plumbing + Controls). This position will interact with a wide stakeholder base internally and externally to Facilities.
• Inform and influence the development of GxP strategy and policy and Infrastructure Engineering management; leadership in GxP regulatory compliance across all 2seventy sites, in full alignment with corporate business strategies.
• Lead the delivery of GxP engineering needs for FDA/MHRA/EMEA compliant facilities within 2seventy bio.
• Ensure that processes and systems for the Infrastructure Engineering services meet all national, corporate and local regulations in the area of regulatory and statutory compliance with a strong focus on cGMP.
• Understand industry trends and developments maintaining an external and cross-business awareness thinking broadly and strategically regarding issues relating to Infrastructure Engineering services so as to drive the delivery of best practice.
• Establish reliability key performance indicators that ensure that the Infrastructure Engineering services are meeting the overall delivery strategies.
• Provide technical consultancy across the wider Facilities organization in core discipline as required, and utilize external providers for detailed technical assessments as necessary.
• Take responsibility as the system owner of multiple complex infrastructure systems used throughout the facility.
• Oversee the delivery of control systems support for critical cGMP data acquisition, alarm, building management and environmental monitoring systems.
• Ownership for all quality related items associated with infrastructure equipment and systems. (i.e Change Control, Deviations, CAPA, SOP’s, Audit support)
• Author SOP’s governing operation and maintenance practices for responsible systems.
• Establish and maintain the Company Asset Register and Maintenance Plans governing reliability and compliance for responsible systems.
• Identify, solicit, and negotiate contracts with service providers as needed for technical suitability and cost-effectiveness.
• Lead investigations and remedial plans at the site for significant equipment failures and process improvements.
• Maintain up-to-date instruction manuals, spare parts lists, schematics, drawings, etc. on all systems and equipment.
• Own the review and acceptance of newly installed and commissioned equipment and systems to ensure that all systems are designed and operating properly prior to acceptance.
• Deliver a strategic approach to Life Cycle Asset Management, ensuring consistent adoption and appropriate planning for capital replacement cycles.

Who you are and what you’ve accomplished:

• Requires a Bachelor's degree in sciences or engineering-related fields
• At least 7+ years of relevant experience in facilities / engineering position with a strong technical knowledge of HVAC, Lab Gases and Electrical is required
• At least 3+ years of experience working in a Biotech/Pharmaceutical GMP setting is require, working with GMP processes and related documentation
• At least 2+ in a role as Technical SME, troubleshooting MEP problems
• Experience with facilities control and monitoring systems is required. Experience with Siemens BMS, Rees Scientific is an advantage
• Experience with a CMMS is required. Experience with Blue Mountain is an advantage
• Must be self-motivated and able to work on multiple tasks with a minimum of supervision
• Ability to communicate effectively