Commissioning and Reliability Engineer
Commissioning Agents, Inc. - Atlanta, GA

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COMPANY OVERVIEW

Commissioning Agents is a leader in establishing new, practical approaches and standards for industry to better deliver and operate manufacturing facilities. Our clients have projects with schedule pressures, financial constraints, business/ energy challenges, and regulatory compliance requirements. When one or more of our employees serve as part of such a project team, the project will have a significantly greater chance of success.

Commissioning Agents has been the standard by which all other similar service providers are judged. We continue to strive for excellence, providing quality teams based on the strength of our corporate reputation.

Commissioning Agents’ employees are well-qualified consultants, engineers or technical specialists. Our employees are highly motivated individuals who are willing to go the extra mile to help our clients achieve their project objectives. We offer our employees a balance of quality of life, financial gain and security, and professional advancement and achievement, and as a result, we offer highly motivated professionals for our clients.

General Duties

  • Commissioning

o Requirements development
o Planning and schedule development
o Design and submittal reviews
o Pre-delivery inspections
o Factory and site acceptance (FAT/SAT) support
o Equipment receipt and installation inspections
o Construction quality oversight/ in-process inspections
o Execution coordination/ management
o System start-up/ shakedown / troubleshooting
o Functional and performance testing
o DCS, BAS/ BMS, and PLC Installation Checkouts

Validation
o Process validation
o Cleaning validation
o Sterilization validation
o Master plans

Qualification
o Protocol execution
o Automation validation
o Facilities, utilities, process equipment
o IQ/OQ/PQ protocol development
o Final reports
o IT systems validation
o Lab equipment

Maintenance/Reliability
o Ability to perform Maintenance & Reliability (M&R) Assessments to identify gaps in M&R Programs and recommend remediation steps
o Act as a discipline engineer in maintenance / modification engineering projects demonstrating skill in Reliability Centered Design (RCD) concepts to eliminate and manage failure modes at the design phase
o Knowledge of and experience with RCM methodologies and tools
o Ability to define and apply RCM and the seven core questions per the Evaluation Standards SAE JA1011 and SAE JA1012
o Ability to explain FMEA and RCM and apply to Risk Assessment approach for Maintenance Strategy & Tactics
o Ability to implement RCM in the CMMS / EAM and in the field
o Lead the development of CMMS / EAM Database starting with the Drawings and Turn Over Packages as well as field walkdowns
o Apply parent child hierarchy, codes and structure to CMMS / EAM Database for future Reliability Analysis
o Ability to Plan, Schedule and Execute work demonstrating regulatory quality GDP documentation practices
o Ability to write & deliver detailed precision work instructions & training
o Ability to write change control orders to support RCM recommendations in an FDA Regulated Industry such as Pharmaceutical and Biotech manufacturing plants
o Ability to recommend the best maintenance strategy and tactics for failure modes by system and component per operating context
o Understand Predictive Technologies and when and how to apply as mitigation strategy for failure modes
o Ability to define either On-Condition Inspection or Predictive Techniques for failure modes that sport a P to F Curve
o Ability to integrate TPM and RCM by creating Autonomous Maintenance Inspections for the Operators as well as PM Inspections for the Technicians using On-Condition Monitoring Concepts
o Ability to apply common sense and justify that recommendations are technically feasible and worth doing
o Understand and apply On-Condition Monitoring during an FMEA /RCM Analysis to optimize the Life Cycle Cost of the Assets
o Ability to integrate cGMP thought process around the product, processes and assets to ensure Regulatory Compliance of the Maintenance & Reliability Program
o Ability to write, apply and follow detailed programs and procedures to standardize the Maintenance and Reliability Programs
o Ability to write, apply & follow detailed SOP’s and Work Plans / Work Instructions including integrating precision specifications & techniques
o Ability to inspire Technicians to understand importance of precision work and ability to influence to continually develop skills
o Participate in reviews & work process improvement initiatives
o Participate as team member in long-term maintenance and modification projects as well as shorter term maintenance engineering consultancy work
o Metrology and Calibration as well as PLC & DCS Experience a plus
o Ability to perform Reliability Analytics on a mature & accurate CMMS

Minimum requirements
o BS degree in an engineering or science-based discipline, or equivalent experience
o Ability to work both independently and in a team environment
o Excellent communication skills
o Detail oriented
o Proficient in use of Microsoft Office products including Word, Excel, etc.
o Ability to understand business needs and regulatory expectations
o Must be willing and able to work overtime, including some weekends
o Must be willing and able to travel both domestically and internationally
o Be able to pass random illegal drug screening.
o Experience in calibration/mechanical/electrical systems.
o Experience in CMMS system (SAP-PM, Maximo)
o Proficient in On-Condition, Predictive, Preventative & RCM Maintenance activities, asset care, uptime time, Root Cause Analysis, OEE & TPM
o Experience with the development and implementation of a local TPM Program including a roll-out plan.

Qualified candidates must be legally authorized to be employed in the United States. CAI does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


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