Facilities and Engineering Manager

2 months ago

Boston, United States Elektrofi Inc Full time
Job DescriptionJob DescriptionDescription:

ABOUT ELEKTROFI

Elektrofi is revolutionizing the delivery of biologic therapies by giving patients the ability to control how they want to receive and benefit from life-changing medicines. Our breakthrough ultra-high concentration microparticle technology platform resolves the limitations associated with intravenously biologic therapies by enabling convenient at-home subcutaneous self-administration. With a focus on monoclonal antibodies, therapeutic proteins, and other large molecule drugs, we create, develop, and commercialize subcutaneous biologic therapies in collaboration with strategic partners. We believe a patient-centered healthcare approach can lead to a healthier world. We are headquartered in Boston and innovate globally. We are Formulating the Future of BiologicsTM.


POSITION SUMMARY

Elektrofi is seeking a motivated individual to join our biotech company as a Facilities & Engineering Manager to join our Technical Operations team in supporting the development of the novel Elektrofi formulation platform. This role will be managing the day-to-day facilities and engineering activities of Elektrofi’s existing R&D facilities fully onsite in Boston, MA. The most successful candidates will possess a solutions-oriented mindset, remain adaptive to appropriately adjust to the business’s needs, and operates with a detail-oriented approach. In this role you will join a growing, multidisciplinary team of scientists/engineers and industry professionals.


KEY RESPONSIBILITIES

· Lead the development, implementation, and maintenance of a fit for purpose Asset Lifecycle Management System for all assets.

· Conduct Gap Assessment of current Calibration and Maintenance Program for all assets.

· Responsible for selection of vendors, execution of work orders by vendors and acting as a primary point of contact for facility maintenance services at Boston facility. Ensure that projects are delivered on time, to specification and on-budget.

· Ensure projects are handed over to "customers" (scientists, engineers, quality, etc.) effectively and efficiently.

· Complete post CAPEX project appraisals to ensure lessons learned are applied and shared appropriately.

· Gather and compile requirements from various ownership functions to generate clear user requirement specifications for new assets as needed.

· Lead the installation, qualification, and commissioning of company assets.

· Responsible for developing Preventative Maintenance (PM) procedure for all newly acquired equipment.

· Responsible for partnering with Elektrofi EHS throughout the lifecycle of projects and ensuring that project implementation and equipment usage is in conformance with all local, state, and federal regulations.

· Complete analysis of potential suppliers/vendors and select best option for the business and support equipment purchase negotiations.

· Develop facility layouts and other site drawings to identify material, waste, and personnel flow.

· Support Operations team in optimizing performance of lab and facilities.

· Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.

· Provides guidance and leadership to engineering team regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.

· Provide timely verbal and written updates to stakeholders & leadership.

Requirements:

MINIMUM QUALIFICATIONS

  • Required: Bachelor’s degree in engineering, or equivalent technical experience plus demonstrated competence, with 5+ years of significant engineering and/or operational experience.
  • Minimum 5 years of pharmaceutical or biotech industry experience in increasing levels of responsibility and operational excellence preferred.
  • Has a career history marked by a consistent series of technical or engineering contributions and accomplishments as it relates to facility, utility, and equipment.

PHYSICAL REQUIREMENTS

  • Ability to perform physical tasks such as: lifting up to 40 pounds, moving solvent barrels, climbing ladders, and conducting inspections.
  • Ability to perform lab and mechanical room maintenance tasks including but not limited to working with air handler, electrical, and plumbing systems.
  • Ability to work in various environmental conditions (e.g., indoors, lab environment, hot/cool conditions).

SKILLS

  • Possesses a strong technical knowledge and application of concepts, practices, and procedures.
  • Works on complex problems where analysis of situations or data involves multiple competing factors and can exercises judgment and advise management as to the appropriate actions.
  • Proficient in the use of Computer-Aided Design (CAD) to update facilities, utilities, P&ID schematics, equipment, and tooling drawings.
  • Interacts well with diverse groups within engineering and maintains strong working relationships with internal and external collaborators.
  • Possesses interpersonal skills to negotiate and reconcile differences.
  • Has a technical background in life sciences, pharmaceutical, biologics, or similar industries.
  • Understanding of GLP principles, concepts, practices, and standards.
  • Organizational skills for day-to-day activities and excellent communication and interpersonal skills.
  • Ability to drive safety, quality, functional, technical, and operational excellence.
  • Ability to collaborate and communicate in a cross-functional team environment while making timely decisions and knowing when to escalate.

Our unique strength lies in transforming pioneering ideas into concrete, life-transforming solutions. To realize this ambitious vision, we are dedicated to nurturing an in-office work ethos. While remote work has its merits, it does not constitute a fundamental aspect of our working approach. As part of our commitment to enhancing the in-office experience, we provide all employees with a commuter assistance program, offering support of up to $315 per month. Please apply at elektrofi.com/careers.

EEOC Statement:

Elektrofi provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

To all agencies, please, no phone calls or emails to any employee of Elektrofi about this requisition. All resumes submitted by search firms/employment agencies to any employee at Elektrofi via email, the internet, or in any form and method will be deemed the sole property of Elektrofi unless such search firms/employment agencies were engaged in writing by Elektrofi for this requisition and a valid agreement with Elektrofi is in place. If a candidate submitted outside of the Elektrofi agency engagement process is hired, no fee or payment of any kind will be paid.


All candidates must be legally authorized to work in the United States for any employer without sponsorship now or in the future.

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