Equipment Engineer II

Cook Medical•Pittsburgh, PA

63d•Onsite

About The Position

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.

Requirements

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

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