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Reliability Engineer cGMP Risk aseptic processing Allendale, NJ ref

2 months ago

Allendale, United States ESR Healthcare Full time

Reliability Engineer cGMP Risk aseptic processing Allendale, NJ ref

Skills: Reliability Engineer, cGMP, Risk Assessments, Root Cause Analysis, Project Management

Experience level: Associate Experience required: 3 Years Education level: Bachelor’s degree Job function: Engineering Industry: Biotechnology Compensation: View salary Total position: 1 Relocation assistance: No Visa : Only US citizens and Greencard holders The Reliability Engineer is responsible for providing both tactical and strategic support for the development, implementation, monitoring, and continuous improvement of Reliability Solutions over the entire lifecycle of Site Assets and Capital Projects.

Essential Functions and Responsibilities

Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.

CMMS Development

Develop, maintain and update the Proactive Maintenance and Condition Monitoring programs within the organization.

Authorize all final changes to the PM/PdM program and ensure that program changes are properly entered into CMMS

Integrate Asset Criticality Assessment results into Asset records and maintenance strategy

Assist in developing a spare parts program strategy in the CMMS and ensure required changes are documented and communicated

Assist in establishing clear workflows & responsibilities for Work Order and Job Plan execution and approval, system administration, and training in use of the system.

PM Optimization Program - review the existing maintenance program for opportunities to:

Identify and remove low value-added tasks

Revise PM intervals based on task type, asset usage, environment, and industry guidelines

Replace time-based intrusive tasks with condition based non-intrusive tasks where applicable

Develop Failure Modes and ensure all Job Plan tasks are tied to a failure mode

Strengthen work packages (task instructions, parts, and tools)

Procedural Development

Provide oversight and direction to implement a life cycle Asset Management program across the organization. This includes defining the Vision, providing guidance to Site teams, setting expectations, establishing and monitoring metrics, interfacing with numerous groups and communicating the Vision to key Stakeholders across the Organization. This effort also involves defining the interfaces with other Business Enterprise systems supported across HCATS

Assist in developing a site Criticality Analysis approach and update as required.

Devise methods to develop and improve engineering standards and work practices within the department

Develop Continuous Improvement strategies and lead teams within areas of responsibility

Develop procedures and specifications for the reliability maintenance aspects of existing and new equipment and systems.

Analytics

Monitor and drive the effectiveness of the Reliability & Maintenance program.

Develop reliability metrics to evaluate activities and processes to assess Capital Effectiveness. Identify opportunities to provide improvement through benchmarking of metrics, personal knowledge, and interfacing with others.

Evaluate and trend critical equipment performance and history and develop proactive strategies to minimize the occurrence of the failures. Compare system and components failure rates with industry norms.

Identify Bad actors by analyzing equipment history using CMMS data, spare parts utilization, PdM history, etc.

Investigation and Quality Support

Provide support in Quality investigations relating to critical equipment failures

Conduct Risk Assessments (FMEAs) and Root Cause Analyses for critical equipment failures

Ensure that all CAPAs (Corrective Actions, Preventive Actions) are included in the proactive maintenance program updates

Ensure that change control requirements including testing and documentation are always adhered to within the department and the Asset Management Program as a whole.

Project Support

Defining and supporting Processes, Systems and Approaches that provide significant improvement in Capital Effectiveness, contribute to improved Operating Performance, promote consistency across the Network and support compliance, reliability, energy efficiency, ergonomics, operability, etc. initiatives with all project designs

Providing support for the ongoing development of Sites and facilities through development of Site Master Plans. This includes assessing facility designs with EHS, Regulatory and Operational requirements and promoting the use of innovative designs that provide improved reliability and performance

Assist in the continued development of the Capital Project Management Process within the organization. This includes collaboration with other Departments to ensure best practices are shared across the site network, implementing Engineering Design guidelines as appropriate and contributing to optimization of the RFP, DQ, Commissioning, and ETOP Processes.

Manage smaller reliability improvement projects in areas such as yield loss improvement, efficiency, PdM, TPM, lean processes

Participate with Corporate communities of practice and engineering excellence forums to ensure compliance of the site while providing SME (Subject Matter Expert) lead on site initiatives.

Qualifications

Bachelor’s degree in Engineering or relevant field

A minimum of 3 years post college graduate or equivalent experience required

Knowledge and application of reliability methodologies and tools (e.g. Root Cause Analysis, FMEA, Structured problem solving, Lean and Six Sigma) is preferred.

Previous experience in a Pharmaceutical/Life Sciences/Medical Device environment preferred

Hands-on maintenance and engineering experience required

Both tactical and strategic knowledge of the principles of preventive & predictive maintenance, reliability centered maintenance and equipment performance standards

Experience preparing site assessments, FMEA reports and the ability to produce sample documents if requested

CMRP Certification preferred

Experience working with a CMMS package – Maximo preferred

Competencies/Candidate Profile

Candidate must be self-motivated and be able to quickly ramp-up on the understanding of existing plant processes.

Demonstrated diagnostic and problem-solving skills in a team environment

Acts decisively

Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.

Communicates effectively

Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.

Capable of working both as part of a team or autonomously – previous team leadership and facilitation skills will be a plus.

Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.

Fosters continuous improvement and innovation

Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies.

Desire to learn and develop career within organization

Fosters integrity and honesty

Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.

Manages projects and functions

Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.

Working Environment

The job requires communication with the site leadership during and after working hours as well as working with challenging clients, contractors and advisory personnel.

Aseptic Processing Standards

Previous experience in a Pharmaceutical/Life Sciences/Medical Device environment preferred. This includes an understanding of Industry cGMP standards and aseptic processing practices.

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