Arranta Bio is a rapidly growing and dynamic bio-pharmaceutical contract development and manufacturing organization (CDMO). Our vision is to be the best in class CDMO providing development and GMP manufacturing services to microbiome innovators within the pharmaceutical industry. Therapies focused on the human microbiome are exhibiting incredible potential towards revolutionizing disease etiology and associated medical treatments. Arranta Bio's mission is to build a world class organization which provides microbiome bio-pharmaceutical innovators with a single source of supply from early process development through clinical and commercial GMP finished product.
WHO ARE WE
Arranta hires people who are committed and passionate to the goal of bringing life enhancing products to patients. We want top talent who will render ideas and a relentless desire towards accomplishing our mission; when a job becomes a passion, it makes you feel ALIVE.
Here at Arranta Bio, we embrace ALIVE - our core values that we live and breathe daily! We are Agile, Leading, Innovating, Value Creating, and Engaging.
We embrace our challenges as opportunities.
We are empowered to think and act.
We never settle; we strive to improve through purposeful creativity.
We build aligned teams who learn, grow, and deliver.
We are committed to building strong relationships.
Are you ready to come ALIVE with a daring and intrepid team? Don't wait another minute; Apply today!
Reporting to the Facilities and Maintenance Manager, this position will be responsible for HVAC, High Purity Water Systems (WFI), GMP facilities/utilities, and grey utilities supporting Arranta Bio's Plasmid and Microbiome Manufacturing Facility in Watertown, MA. This position will provide engineering support for utilities and HVAC to the campus, support the execution of day to day operations, projects and troubleshooting. This position will lead investigations relating to non-conformance events in partnership with Quality, IT, and Manufacturing.
ESSENTIAL JOB FUNCTIONS
- Supervise and lead Plant Engineers responsible for MEP, HVAC, and I&C support for the Watertown Campus.
- Provide technical guidance, coaching, and work prioritization assistance with the Plant Engineers. Provide direct engineering support for the clean utilities including WFI generation, storage, and distribution and process gases.
- The engineer will provide technical support of grey utilities including chilled water, steam, boilers, and condensate systems, including the associated BMS controls.
- GMP HVAC support is to include expertise in clean room design, air distribution, HEPA filtration and certification, and pressure differential and pressure alarming strategies.
- Troubleshooting equipment to determine root cause of failure modes, owning Corrective/Preventative Actions and associated change controls, providing input into preventative maintenance plans, assessing change controls, and continuous improvement initiatives.
- Provide a high level of customer support to the Facilities and Manufacturing teams, the Senior Engineer must develop a deep knowledge of the utility and HVAC requirements of each of the manufacturing areas.
- The ability to collaborate cross-functionally with stakeholders to determine the best path forward to identified issues by balancing technical, compliance, and business objectives. The Senior Engineer needs to be able to drive results by owning and completing the subsequent projects including high quality technical writing within the required quality systems and meeting the project timelines to ensure the production schedule is not impacted.
- Drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor, in addition to reviewing and guiding the work and performance of contractors. The Senior Engineer will have specific safety objectives to include proactively evaluating the safety of the operation of the utility and HVAC equipment and propose and implement safety improvements.
- The Senior Engineer must always work in a safe manner by adhering to all safety procedures and have a proactive safety mindset. The Senior Engineer will participate on project teams through all phases of engineering projects in the HVAC and utility areas including conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification of facilities and/or equipment.
Experience and Skills
EDUCATION AND/OR EXPERIENCE
- Applicant must have familiarity with biotechnology operations, including GMPs.
- Knowledge of clean room design, GMP HVAC, grey utilities, and GMP utilities.
- Excellent interpersonal and communication skills (verbal and written) are required.
- Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions.
- Technical writing skills required.
- Must be able use his/her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions.
- Must be able to be able to find true root cause and path forward for complex problems.
- Familiarity with Excel, Word, and PowerPoint are required, and basic statistical analysis techniques are preferred.
- Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.
- Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.
- Ability to represent Arranta Bio's interests, objectives and policies in a professional and responsible manner.
- Experience in large engineering capital projects is preferred.
- A minimum of eight years professional experience required in engineering, facilities or operations.
- A minimum of five years relevant experience in cGMP environment is desirable.
- BS in Chemical or Mechanical Engineering.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- The employee is frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear.
- The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl.
- The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, and ability to adjust focus.
- In the performance of the duties of this job the employee is required to travel occasionally, drive a motor vehicle.
- Communicate using telephone and e-mail.