5359 Instrument Engineer III
Summary:
This position reports to the Sr. Manager of Utilities Frontline Engineering in the Facilities and engineering Department.
The Instrument Engineer is an instrument subject matter expert and supports manufacturing and utility operations at the Vacaville site.
Job Responsibilities:
Technical:
Identify, analyze, and design improvements and capabilities for facility, utility, process, and equipment systems.
Develop and maintain engineering documentation such as PDF’s, P&ID’s, design drawings and specifications, design reviews, and protocols (FAT, SAT, and IQ).
Support development and review of project documentation such as schedules, budget, URS, PEP, RFQs, Contractor Bid Packages, Statements of Work, and Credit Applications.
Drive and manage the planning and design phases including project initiation and
conceptual/basic/detailed design depending on the assignment.
Drive and manage FAT, SAT, commissioning, and installation qualification.
Support debug, operational and performance qualification, and handover to operations.
Project Management:
Develop and maintain project documentation noted above.
Manage construction phases including contractors, construction supervision, business processes, change orders, punch-list, turnover, and closure.
Provide instrumentation engineering expertise to support investigations, CAPA’s, audits, inspections, permits, and other technical requests.
Provide 24/7 instrumentation support.
Support Global Engineering on major projects in a user team role.
Collaborate with peers in continuous improvement of technical infrastructure including standards, practices, specifications, procedures, and business processes.
Provide Instrumentation oversite as a Member of the global Engineering Master Specification Team.
Explore new Instrumentation technologies for implementation locally and globally.
Leadership & People Management:
Serve as primary contact for the instrument engineering team.
Lead instrument design teams, project teams, and contract engineering personnel.
Mentor less experienced Engineering staff.
Lead engineering-related site or network initiatives.
Provide technical guidance to Instrument Services Personnel.
Education:
BS Engineering degree from an accredited university.
Electrical, mechanical, or chemical engineering is preferred.
Experience:
5-7 years of work experience in a GMP manufacturing environment for SE05.
8-11 years of work experience in a GMP manufacturing environment for SE06.
Knowledge/Skills/Competencies:
Strong understanding and demonstrated ability with engineering principles and techniques.
Knowledge of FDA and EMA cGMP’s, applicable building codes, and related regulations.
Proficiency in ISA standards and practices for instrumentation.
Knowledge of calibration theories, techniques, and practices.
Knowledge of project lifecycle including initiation, design, construction, and commissioning/validation.
Effective communication and interpersonal skills with technical, operations, maintenance, quality, and senior management personnel.
Work Environment/Physical Demands/Safety Considerations:
Work environment includes office, utility, clean room, warehouse, laboratory, roof, and outdoors.
Physical demands require sitting, standing, walking, climbing stairs, ladders, scaffolding, and cleanroom gowning.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.