Equipment Engineer II

Overview:

Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine. We're investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you're curious, motivated by helping others, and driven by integrity, we invite you to apply.

Perform activities associated with the equipment program related to equipment used within the AMDC manufacturing process and in support labs.

Responsibilities:

• Maintains a solid understanding of the equipment used within the cGMP manufacturing process and utilizes that understanding within projects, risk assessments, decision making, audit support, and day-to-day operations.
• Assists in the development of equipment-based programs (in collaboration with the Metrology Department, process owners and Quality Assurance).
• Provides technical support for equipment associated with the cGMP manufacturing process, and provides feedback associated with internal and external queries relating to equipment used in the cGMP manufacturing process, including audits.
• Completes equipment related documentation for cGMP and non-cGMP equipment systems.
• Participates and leads investigations, CAPAs, and change controls pertaining to process equipment.
• Guides and trains engineers, process owners, and system owners on equipment related functions as required.
• Performs commissioning and decommissioning activities of equipment, including protocol development and execution.
• Creates and maintains all procedures associated with operation, maintenance, and calibration of equipment, including use of CMMS system.
• Implements CAPAs stemming from investigations or observed trends and ensures the CAPAs are effective and corrective/preventive for future deviations.
• Coordinates with process engineers/owners in the implementation of large equipment changes that impact the GMP manufacturing process.
• Leads risk mitigation activities required from Equipment Engineering.
• Participates in projects, technology transfer activities, risk assessments, and steering committees/boards associated with the cGMP manufacturing process as the Equipment Engineering SME.
• Exemplifies Cook MyoSite Core Values
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• This position requires an ongoing commitment to upgrading knowledge, job skills and abilities in addition to competency related to all duties and responsibilities listed above.
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization to achieve company goals
• Trainability
• Must have effective verbal, written and interpersonal skills
• Able to prioritize and operate proactively
• Capable of handling multiple responsibilities and/or projects
• Must possess the ability to understand and follow complex procedures and systems
• Must exhibit well developed skills in prioritizing, planning, organization, decision making, and time management
• Must demonstrate critical thinking and proven problem-solving skills
• Able to analyze situations or data
• Strong interpersonal skills resulting in exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations

Qualifications:

Undergraduate degree in Engineering or Life Science or 8 years direct, relevant experience in Bio/Pharmaceutical to provide a comparable background

Minimum of 6+ years' experience in biopharmaceutical or healthcare industry

A Senior Equipment Engineer should have a strong mechanical background stemming from educational experience or industry experience. They should be very well acquainted with the systems used within the cGMP manufacturing process.

Proficient knowledge of Microsoft Office software, and other general office equipment.

Ability to learn and support new systems and applications, and the ability to provide technical training to end users.

In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

Up-to-date with changes in technology and the business implications/applications of new technologies

Full Time On Site

Laboratory Setting (Non-Production: General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

Physical Requirements:

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.
• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.
• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.
• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.
• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and facial mask (if required) on a regular basis.
• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

Employee that does not interact with Healthcare Professionals

Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations

At Cook MyoSite, we don't just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.

This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.