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Manager, Metrology
2 months ago
At Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at the core of everything we do, and we’re committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future.
Position Summary
The Editas Facilities & Engineering team is looking for a Manager of Metrology & Lab Systems Maintenance. This individual, reporting to the Senior Director of Facilities & Engineering, will be responsible for managing Metrology & Lab Systems maintenance, including any employees, contractors, and external vendors to help meet the needs of the business. This individual will be responsible for the coordination and execution of all routine and non-routine maintenance associated with all instrumentation and lab systems while ensuring the proper GMP procedures are followed and good documentation is executed. This position will split time between Devens and Cambridge, MA for the remainder of 2024 and will be based full-time in Devens, MA starting January 2025.
Key Responsibilities:
As the Manager, you will be responsible for:
- Managing Metrology and Laboratory System services to maintain critical business operations.
- Using solid analytical skills, the incumbent can recognize problems of moderate scope and complexity, and independently, develop potential solutions and courses of action according to cGMP policies and procedures.
- Represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge.
- Own and maintain procedures and work instructions for asset management, calibration, and maintenance. Identify improvements to asset management and metrology processes.
- Manages metrology and lab system maintenance staff to properly maintain all equipment and instrumentation.
- Is accountable on-boarding of assets and defining calibration ranges, tolerances, and intervals.
- Co-ordinate with vendors and system owners for quotes, scheduling, and troubleshooting for calibration, preventive maintenance, and qualification services.
- Completes on-demand and scheduled work orders and asset updates in CMMS systems.
- Facilitate and support non-conformance reports in CMMS systems.
- Manages contracts, POs and invoices to support OEM calibrations, outsourced calibration staff, equipment, instruments, standards and parts.
- Drives Metrology and Laboratory System operating budget within target goals for all contracted services and expenses.
- Performs periodic verifications of asset inventories.
- Performs database updates to reflect changes found in quarterly inventory verifications (change, new assets, assets not found).
- Periodically work on project management assignments with broadly defined objectives.
- Solve non-routine issues, challenges, and problems within field of specialization.
Requirements
Required Qualifications:
The ideal candidate will possess:
- BS degree in electrical, mechanical, or relevant engineering discipline with a minimum 5 years of Metrology and Laboratory System Maintenance experience supporting and troubleshooting.
- Minimum 2 years experience managing personnel.
- Thorough knowledge of cGMP in the pharmaceutical industry
- Extensive knowledge of pharmaceutical, manufacturing and laboratory systems and equipment
- Knowledge of IMTE (Inspection, Measurement, and Test Equipment), General understanding of control systems including PLCs, HMIs, Building Automation Systems, CCMS (Computerized Calibration Management Systems)
- Strong experience in coordinating outside contractors in support of laboratory system operations and maintenance, including system and equipment repair, upgrade, installation, start-up, and commissioning.
Preferred Qualifications:
Additionally, candidates with the following attributes are preferred:
- Maintains a high level of multi-tasking ability in conjunction with proven organizational skills.
- Ability to work off schedule and weekend hours to provide site operational support when necessary.
- Strong written and verbal communication skills along with excellent leadership skills that encourage empowerment and ownership within the team and organization.
- Proficient at writing well-formulated emails and notifications
- Ability to effectively communicate with employees, contractors, and vendors.
- Familiarity with FDA / cGXP environments and associated compliance regulations
- Adept in Microsoft Office Suite Word, Excel, Visio, Project and Outlook, and the ability to learn new software, such as enterprise business, building management, security, and maintenance management systems.
- Familiarity and experience with systems such as BMRAM (Blue Mountain Regulatory Asset Management), Elemental Machines, MAXIMO, Siemens BAS is beneficial.
Benefits
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.