Validation Engineer
: Job Details :

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.