Equipment Commissioning & Qualification Operations Engineer

Summit, NJ

Apply Apply with LinkedIn
Save

Type: Contract

Experience: 0

Category: Scientific & Clinical

Brand: Joule

Job ID: 290366

Date Posted: 09/20/2022

Start Date: 10/24/2022

End Date: 10/24/2023

Shortcut: http://jobs.systemoneservices.com/xU6pdZ


Title: Equipment Commissioning & Qualification Operations Engineer

Location: Summit, NJ

Start date: ASAP

Responsibilities:

  • The Equipment Engineer, Equipment Commissioning & Qualification Operations (S6A) supports the successful operation of laboratory and clinical manufacturing operations at their home site through interaction with internal team members and internal customers as well as external service providers.
  • With minimum supervision and given general instructions, this individual carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope.
  • As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.
  • The incumbent may be asked to lead small to medium sized projects in their area of responsibility and will be called upon to create and revise work processes or procedures that impact their immediate function or organizational unit.
  • The incumbent will be involved with writing deviations, investigations and supporting the implementation of change controls.
  • Executes equipment calibration, preventative maintenance, performance verification and repair activities in both laboratory and manufacturing areas.
  • Supervises vendors for calibration, preventative maintenance, performance verification and repair functions.
  • Reviews and approves vendor executed calibration, maintenance, repair, and performance verification records for accuracy, completeness and compliance to Bristol-Myers Squibb standards.
  • Works closely with and enters data into the site CMMS system.
  • Ensures all calibration, PM, and performance verification records are filed appropriately after approval.
  • Writes and supports Change control and relevant action
  • Writes and supports deviations and investigations that result from calibration or performance verification failures along with developing and supporting the implementation of corrective and preventative actions.
  • Support the development, revision and review of written procedures for calibration, preventive maintenance and performance verification of equipment.
  • Support the development, review and approval of calibration and maintenance plans in site CMMS system.
  • Supports the execution of equipment performance verification and process improvement studies.
  • Adheres to all policies and procedures which govern the ECQ team and the equipment they manage in order to ensure compliance is held to the highest standard.
  • Promotes and Provides Excellent Customer Service and Support
  • Regularly reviews, prioritizes and promptly responds to customer equipment performance verification and support requests.
  • Provides technical support and guidance on calibration, equipment performance verification and validations issues. Interfaces with customers to ensure all expectations are being met.
  • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
  • Work with planning group to ensure system is updated as calibration, maintenance and performance verification activities are performed.
  • Maintains all required Corporate, Facilities and EHS training as required.
  • Adheres to all safety procedures and hazard communication.
  • May be called upon to act as SME in both internal and regulatory audits.

Requirements:

  • BS or Associate in Engineering or Metrology preferred.
  • Minimum 2 years’ experience in FDA-regulated industry
  • Experience working directly with biologics manufacturing equipment (Single Use Bioreactors, Chromatography, TFF skids, single use mixer, osmometer, Autoclave, Spectro photometer etc.) preferred.
  • Knowledge of cGMP in the pharmaceutical industry
  • Excellent computer skills including knowledge of calibration management and environmental monitoring systems
  • Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required
  • 2 years of maintenance coordinating / planning experience, preferably in a laboratory environment.
  • Experience working in a clinical environment preferred.
  • Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices.
  • Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce where individual initiative, accountability to the team, and professional maturity are required.
  • Strong multi?tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
  • Highly proficient computer skills in Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Innate ability to learn new software, such as corporate intranet and enterprise business.
  • Working knowledge of scheduling software and systems, and inventory management systems, mainly Blue Mountain RAM,Meximo
  • Ability to interact effectively with Manufacturing Operation, QA and Facilities groups.
  • Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
  • Ability to sit, stand, walk and move within workspace for extended periods
  • Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
  • Will likely spend >70% of their time in a laboratory or manufacturing environment. Will be required to enter laboratory or GMP process areas donning proper gowning / lab coats or PPE such as safety glasses and shoes.
  • Ability to work safely and effectively when working alone or working with others.

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


  • ECQ Metrology Engineer

    Summit, NJ

    Title: ECQ Metrology Engineer (3rd Shift) Location: Summit, NJ Start date: ASAP Responsibilities: The Metrology Engineer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial manufa...

    Date Posted: 11/23/2022 Recommended

  • ECQ Metrology Engineer

    Summit, NJ

    Title: ECQ Metrology Engineer (1st Shift) Location: Summit, NJ Start date: ASAP Responsibilities: The Metrology Engineer, Equipment Commissioning & Qualification Operations supports the successful operation of laboratory, clinical and commercial manufa...

    Date Posted: 11/16/2022 Recommended

  • Calibration Tech

    Hopewell , NJ

    Title: Calibration Technician Location: Hopewell, NJ Schedule: Monday – Friday (8am-5pm) Type: Contract to Hire Start date: ASAP Responsibilities: Calibrates and repairs manufacturing and laboratory equipment in accordance with SOPs, ensures proper doc...

    Date Posted: 10/18/2022 Recommended

  • CSV Engineer

    Summit, New Jersey

    Title: CSV Engineer Location: Summit, NJ Start date: ASAP Responsibilities: The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal ...

    Date Posted: 10/26/2022 Recommended

  • Industrial Maintenance Technician I/ New Castle

    New Castle, Pennsylvania

    Create A Better Future For Yourself…Your Future Begins Here! System One is working with a client launching a full-time, entry-level, 18–24 month training program for Industrial Maintenance Technicians. This amazing opportunity is available to trade sch...

    Date Posted: 11/03/2022 Recommended

  • Industrial Maintenance Technician I/ Navasota

    Navasota, Texas

    Create A Better Future For Yourself…Your Future Begins Here! System One is working with a client launching a full-time, entry-level, 18–24 month training program for Industrial Maintenance Technicians. This amazing opportunity is available to trade sch...

    Date Posted: 11/03/2022 Recommended

  • Industrial Maintenance Technician I/ Irvine

    Irvine, Pennsylvania

    Create A Better Future For Yourself…Your Future Begins Here! System One is working with a client launching a full-time, entry-level, 18–24 month training program for Industrial Maintenance Technicians. This amazing opportunity is available to trade sch...

    Date Posted: 11/03/2022 Recommended

  • Mechanical Maintenance Technician - Vandergrift

    Vandergrift, PA

    System One is currently looking for a Mechanical Maintenance Technician for our client's manufacturing facility in Vandergrift, Pennsylvania. Our client's Mechanical Maintenance Technicians are part of a highly skilled team that is critical to ensuring...

    Date Posted: 10/24/2022 Recommended

  • Mechanical Maintenance Technician - Washington

    Washington, PA

    System One is currently looking for a Mechanical Maintenance Technician for our client's manufacturing facility in Washington, Pennsylvania. Our client's Mechanical Maintenance Technicians are part of a highly skilled team that is critical to ensuring ...

    Date Posted: 10/24/2022 Recommended

  • Electrical Maintenance Technician - Brackenridge

    Brackenridge, PA

    System One is currently looking for an Electrical Maintenance Technician for our client's manufacturing facility in Brackenridge, Pennsylvania. Our client's Electrical Maintenance Technicians are part of a highly skilled team that is critical to ensuri...

    Date Posted: 10/24/2022 Recommended

  • Electrical Maintenance Technician - Washington

    Washington, PA

    System One is currently looking for an Electrical Maintenance Technician for our client's manufacturing facility in Washington, Pennsylvania. Our client's Electrical Maintenance Technicians are part of a highly skilled team that is critical to ensuring...

    Date Posted: 10/24/2022 Recommended

  • Electrical Maintenance Technician - Vandergrift

    Vandergrift, PA

    System One is currently looking for an Electrical Maintenance Technician for our client's manufacturing facility in Vandergrift, Pennsylvania. Our client's Electrical Maintenance Technicians are part of a highly skilled team that is critical to ensurin...

    Date Posted: 10/24/2022 Recommended

  • Electronics Technician II

    Hubbard, Ohio

    Are you the one? Join the best; be the best! Your future belongs here! The Electronic Technician is responsible for identifying & repairing equipment malfunctions, as well as calibrating and performing preventive maintenance on equipment and systems. W...

    Date Posted: 11/03/2022 Recommended

  • Compliance Specialist

    Summit, New Jersey

    Title: Compliance Specialist Location: Summit, NJ Start date: ASAP Responsibilities: The Compliance Specialist, Equipment Commissioning & Qualification, supports the successful operation of facility, laboratory, and business functions at multi?use site...

    Date Posted: 10/26/2022 Recommended

  • Validation Engineer

    Summit, NJ

    Title: Equipment Validation Engineer Location: Summit, NJ Start date: ASAP Responsibilities: The Equipment Validation Engineer supports the successful implementation of laboratory and manufacturing equipment and utilities at multi-use sites through int...

    Date Posted: 11/08/2022 Recommended