Validation Engineer

6 days ago


Allendale, United States Control Associates, Inc. Full time

About the Company - Setting new standards for industrial process automation solutions in the metropolitan New York City tristate area, Control Associates, Inc. is a premier provider of process automation systems & software, valves, measurement solutions, pressure management, asset reliability and data management solutions. We are looking to hire a Validation Engineer who will be based out of our headquarters in Allendale, NJ. Established in 1933, Control Associates along with its global process automation business partner, Emerson, specializes in supporting the process control equipment and service needs of the following industries: Life Sciences, Natural Gas Distribution & Transmission, HVAC, Power, Chemical, and Downstream Hydrocarbons.



About the Role - The Validation Engineer has primary responsibility for driving overall quality performance and compliance throughout the organization and customer-driven projects by defining, implementing, and maintaining the validation program.



Responsibilities


  • Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously.
  • Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility.
  • Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports.
  • Write reports summarizing results and statistics for all equipment, products, or process validation projects.
  • Work with end users and process owners to collect data to support protocol requirements, analyze data collected, and create validation reports.
  • Coordinate with end users and process owners to lead the development of validation protocols.
  • Learn and understand the applicable technology and engage in technical discussions.
  • Identify areas and opportunities to improve manufacturing facilities, processes, and equipment.
  • Provide consultation to other departments performing validation activities.
  • Ensure the validation program meets FDA and Site-Specific requirements.


Qualifications


  • Bachelor’s degree in engineering or science and 2-5 years of related experience is required.
  • 2+ years’ experience in the biotech, pharmaceutical, or medical device industry in developing and deploying Quality Systems, process controls, and continuous improvement methods.
  • Must have validation experience of GMP IT or Automation Systems, (2+ years preferred)
  • Test protocol or test script authoring
  • Test execution
  • Documentation of failures or non-conformances
  • Resolution of failures or non-conformances
  • Familiarity with electronic validation/QMS systems such as Veeva, Master Control, Valgenesis, Service Now, or KNEET.
  • Knowledge and working application of FDA, and cGMP requirements.
  • Intermediate knowledge and working application of Validation Principles and guidelines and industry practice.
  • Knowledge in Calibration and Environmental Monitoring Programs.
  • Knowledge and working application of standard operating procedures.
  • Ability to multi-task and methodically manage projects.
  • Demonstrated ability to accomplish goals while working across departments is required.
  • Demonstrated strong analytical problem-solving, team, and communications/interpersonal skills.




Equal Opportunity Statement - Include a statement on commitment to diversity and inclusivity.



Please note that work visa sponsorship is not available for this role.

This is a direct placement position; third-party contracts are not available.



Normal Working Hours: Monday through Friday 8:00 AM to 5:00 PM.



Control Associates, Inc., offers competitive salaries that include a bonus potential. Excellent benefits, including multiple medical plan choices, vision, and dental insurance with coverage for both employees and dependent family members. Medical and dependent care flexible spending benefits, health savings accounts, company paid for long-term disability and life/ADD insurance plans with a buy up option. Paid time off including vacation days, holidays, and sick days. Our retirement plans include a 401(k) plan (with company match) and an Employee Stock Ownership Plan (ESOP), which is a company-funded benefit that provides additional retirement compensation to qualifying employees. Certification/Training, we provide both in-house and Client/System specific technical training. Control Associates Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, creed, race religion, color, national origin, citizenship, disability, sex, marital status, sexual orientation, familial status, gender, ancestry, or liability for services in the U.S. Armed Forces, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment. Control Associates participates in E-Verify. Click here to view E-Verify Participant.



  • Allendale, United States Coda Search│Staffing Full time

    About Us:A leader in regenerative science, specializing in producing advanced bioabsorbable materials and regenerative technologies for use in medical devices and tissue repair. We are known for innovation, diligence, and urgency in driving medical advancements and continue to focus on creating next-generation materials for medical applications.Position...


  • Allendale, United States Coda Search│Staffing Full time

    About Us:A leader in regenerative science, specializing in producing advanced bioabsorbable materials and regenerative technologies for use in medical devices and tissue repair. We are known for innovation, diligence, and urgency in driving medical advancements and continue to focus on creating next-generation materials for medical applications.Position...


  • Allendale, New Jersey, United States Control Associates Inc Full time

    About the PositionAs a Process Control Engineer, you will play a critical role in ensuring the quality and reliability of our process automation solutions. You will work closely with cross-functional teams to design, implement, and maintain process control systems that meet customer requirements.About UsControl Associates, Inc. is a leading provider of...

  • QC Associate III

    6 days ago


    Allendale, United States Actalent Full time

    Job Title: Associate IIIJob Description Perform testing to help develop methods for flow cytometry and analysis. Perform cell culture and cell counting to analyze for quality control. Assist in analysis for flow methods and complexity testing. Provide input to improve workflow and laboratory activity. Offer input and proficiency in relevant testing. Train...

  • QC Associate I

    5 days ago


    Allendale, United States Actalent Full time

    Job Title: Associate IJob Description Perform testing to help develop methods for flow cytometry and analysis. Perform cell culture and cell counting to analyze for quality control. Help perform analysis for flow methods and complexity testing. Provide input to improve workflow and laboratory activity. Provide input and proficiency in relevant testing....

  • Crane Technician

    6 days ago


    Allendale, United States Lift Solutions Holdings, LLC Full time

    Job DescriptionJob DescriptionDescription:Position SummaryLooking to advance your career with a company that values real skills? Lift Solutions has an opportunity for you. Lift Solutions provides end-to-end industrial lifting solutions. We offer OSHA compliance inspections, crane equipment, aftermarket services and parts for overhead cranes and other lifting...


  • Allendale, United States GEI Consultants Full time

    Description Your role at GEI. We are seeking multiple seasonal ecological restoration field technicians in our Michigan offices (Allendale, Plymouth, Lansing, or Traverse City) to implement project work in the ecological consulting and restoration management fields. Technicians assist with biological surveys and monitoring, ecological restoration, and...


  • Allendale, United States Minaris Regenerative Medicine Full time

    Job DescriptionJob DescriptionManager, QC MicrobiologyAt Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies...


  • Allendale, United States Aerotek Full time

    Job DescriptionJob DescriptionJob Title: Senior Manufacturing TechnicianBachelor Degree in Sciences/Engineering or other related fields requiredPay: $24-$26/hour ; Overtime: $36-$39/hourShift: 7am-3:30pm (Monday-Friday)Location: Allendale, NJRecent college graduate students are welcome! No experience needed. Career Opportunity, in Science Related...