What You Will Achieve: This position is focused on supporting maintenance and operations at a GMP facility to support manufacturing activities in a cGMP environment to meet user needs and QA compliance requirements. The Facilities Engineer will support the Facilities department with maintenance, operations, and projects. The Facilities Engineer will support the on-call facilities tech as needed to support manufacturing operations. In addition to these duties, they will also support the engineering design, construction, commissioning, and operation of the facility.
As an integral part of the engineering design team you will lead reviews for constructability/ operability and systems/equipment selection. You will be the main Organogenesis contact for contractors executing on-site activities. Main tasks assigned to this position include but are not limited to reviewing project scope documentation, ensuring a high level of quality, safety, cost control and adherence to design. You will be responsible for ensuring that all project documentation is up to date, organized, and available for validation efforts. This position is on-site at our Norwood, MA facility.
How You Will Achieve It: - Responsible for HVAC (including cold room) system maintenance and operations
- Supporting of maintenance and repair of clean utilities (Autoclaves, Water systems, etc)
- Facilities Subject Matter Expert (SME) for document review and capital projects
- Own change controls and drive to closure in a timely manner, ensure CMMS data base modifications are properly completed for new equipment and changes to systems.
- Execution of large and small facilities maintenance projects
- Development of PM procedures
- Verification of SOP and system drawing accuracy
- Ensures their work meets QA compliance requirements, that all tasks are completed on schedule, and problems are resolved in an efficient and effective manner.
- Develops specifications and procedures to support maintenance operations.
- Preparation of technical specifications, drawings, and documentation to support project design and execution.
- Oversee construction activities, ensuring compliance with engineering standards, safety regulations, and best practices.
- Support the commissioning and startup of new facilities or systems, ensuring operational readiness upon project completion.
- Document and maintain project records, including design changes, meeting minutes, and
- Provide technical support and guidance to facility operations and maintenance teams, addressing engineering-related issues.
RequirementsWhat You Need to Achieve It: - Bachelor's of Engineering with is preferred, minimum 5 yrs of industry related experience, and experience supporting cGMP manufacturing.
- Hands-on experience with all aspects of clean room operations related to facility system preferred: HVAC, Building Controls, High Purity Water and Steam Systems, Critical Power Systems, & GMP Utilities
- Working knowledge of calibration concepts
- Familiarity with clean construction techniques• Knowledge of control systems and motor control design techniques
- Fundamental knowledge of PC operating systems and industrial networking
- Aptitude with project analysis software such as Excel, and Project, AutoCAD proficiency
- Strong process and mechanical aptitude with a hands-on approach
- Contract negotiating skills
- Good communication and interpersonal skills, organized and detail oriented
What can we offer you? - 401k -- generous employer match with immediate vesting and financial planning resources
- Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
- Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
- Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
- Paid maternity leave and parental leave for all new parents
- Adoption benefits
- Education Assistance Policy - $5,000 per year for all employees
- Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
- Employee Assistance Program
- Generous paid time off including vacation, floating holidays, sick days, and company holidays
- Free parking including an electric charging station (Canton and La Jolla)
- Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint
The anticipated annualized base salary for this role is $119,000-$125,000 and reflects current market data for similarly-sized life science companies and internal equity. Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.
