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Quality - Facility & Reliability Engineer

Company: Net2Source
Location: Warren
Posted on: November 18, 2022

Job Description:

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap Right Talent Right Time Right Place Right Price and acting as a Career Coach to our consultants.

Job Description: Purpose & Scope
The main purpose of the Facility and Reliability Engineer is to maintain a continuous improvement strategy to ensure the Warren, New Jersey site remains in a qualified and GMP-compliant operational state. The Facility & Reliability Engineer supports the successful operation of facility, laboratory, and business functions at the Warren, New Jersey site through interaction with internal customers and external service providers.

The individual is expected to represent the GMP Facilities Department on multi-disciplinary and cross-functional teams and must be able to influence key stakeholders with fact-based, business value knowledge. Collaborative work is required to support ongoing compliance efforts within the GMP Facilities department.

The individual is expected to be able to identify problems, compliance gaps, and unmet needs of moderate scope and complexity, and develop clearly structured plans of action to drive resolution. To be successful in this role the individual must adhere to specific job tasks and processes at both the site and the corporate level.

Required Knowledge, Skills, & Abilities
Knowledge, Skills, and Abilities
Strong understanding of critical building & utility systems including life-safety, lighting, mechanical, electrical, plumbing, clean rooms, compressed gases, security, and site access.
Experience with diagnosing equipment and environmental alarms via building automation and facility management systems.
Experience writing maintenance plans for facility and lab equipment in a GMP-regulated computerized maintenance management systems (CMMS).
Experience performing FMEA to assess equipment and process risks to the business.
Must be able to utilize Lean/Six Sigma methodologies to build a clear path forward when solving problems and conducting investigations.
Ability to quickly learn internal training, quality, and compliance computer systems.
Ability to effectively communicate with employees, contractors, and vendors through well-
formulated emails and technical documentation.
Ability to read, interpret, and revise technical manuals and engineering drawings relevant to the assigned task.
Must be a self-starter who can follow oral and written instructions to work both independently and as a member of a cross-functional team.
Familiarity with FDA / cGxP environments and associated compliance challenges.
Knowledge of FDA & GMP regulations, IBC/IFC building codes, OSHA, NFP, FM, LPDS and UL.
Competencies
Technical writing
Proficiency in MS Office
Failure Mode Effects Analysis (FMEA) for Equipment and Processes
Problem Solving
Technical Troubleshooting
Team Player
Multi-Tasking
Customer Focused
Action Oriented / Tenacity
Lean/Six Sigma Principles (6S/DMAIC/5-why)

Education & Experience
BS degree in mechanical engineering, electrical engineering, or similar engineering field.
Minimum 3-5 years of facilities maintenance/operations experience at an industrial or commercial site and/or equivalent combination of education and experience.
Minimum 3 years of performing investigations within a GMP-qualified quality system.
2-5 years of GMP facility experience preferred.

Key Areas of Responsibility

Compliance
Initiates and supports deviations, investigations, and corrective/preventive action (CAPA) to drive resolution and close site-level compliance gaps.
Investigates Facilities Department deviations to determine root cause and necessary CAPAs by working cross-functionally with site Manufacturing Operations, Supply Chain, Quality, and Engineering.
Initiates deviations for maintenance work orders that are out of compliance.
Promotes and maintains compliance with corporate safety, security, and regulatory policies.
Completes all assigned Corporate, Facilities, GMP and EHS training in the Learning Management System within the first 30 days of the contract.
Reliability
Supports execution of the Corporate Reliability Program at the Warren site as needed.
Reviews deviations, CAPA, and non-scheduled work orders to detect repeat issues and identify solutions that address the root cause to prevent further occurrences.
Uses technical writing skills to establish effective preventative and predictive maintenance plans for GMP Facilities equipment as needed.
Generates SOPs and Work Practices within Clients Document Management System to establish the Use, Maintenance and Calibration plans for GMP Facilities equipment.
Works with internal & external partners to define vendor requirements to support maintenance or calibration plans.
Promotes and upholds all Client corporate values.
Facility Asset Management
Review Bill of Material, OEM manuals, and OEM sequence of operations to generate a robust maintenance program for each asset.
Provides technical expertise, troubleshooting and improved equipment maintenance & reliability strategies to optimize safe, compliant, and efficient operations of all GMP Facilities equipment and instrumentation.
Prepares asset files including equipment data sheets, impact assessments, P&ID & drawings, factory O&Ms, factory maintenance recommendations, maintenance work plans and procedures.

Working Conditions
Physical / Mental Demands:
Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 50lbs.
Ability to sit, stand, walk and move within workspace for extended periods.
Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing, and pulling.
Ability to climb ladders and work in elevated areas.
Environmental Conditions:
Primarily office environment.
Ability to work safely in a laboratory environment as needed with hazardous, radioactive, and infectious materials and waste.
Ability to work safely in an environment with exposure to high temperature / pressure steam, and other fluids, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas, and high voltage energy supplies.
Environment may include working at heights, in cold temperatures, and/or constricted spaces
Ability to work safely when working alone or working with others.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Additional Job Requirements:
None

Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.

Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)

Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX - Cell: (201) xxx xxxx - Fax: (201) 221-8131- Email:

Keywords: Net2Source, Elizabeth , Quality - Facility & Reliability Engineer, Engineering , Warren, New Jersey

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