Plainview, New York, USA
1 day ago
Validation Engineer
Validation Engineer

Location: Central Islip, NY (also available in Hauppauge, NY)

Experience Required: 3+ Years

Industry: Pharmaceutical

Skills: Instrument Validation, Equipment Qualification, GAMP 5, 21 CFR Part 11 Compliance

Role Summary

We are seeking a Validation Engineerto join our team in Central Islip, NY. This role is essential for ensuring that products, equipment, and systems comply with all applicable safety, quality, and regulatory standards. The ideal candidate will have hands-on experience in equipment validation and a strong understanding of pharmaceutical compliance requirements.

Key ResponsibilitiesDevelop and execute qualification protocols and associated reports in alignment with change management processes.Support equipment/system qualifications and validation protocol execution.Collaborate with vendors on qualification activities.Draft procedures for equipment operation and preventive maintenance.Create validation deliverables including:Requirements SpecificationsRisk AssessmentsTraceability MatricesValidation Summary ReportsAssist internal teams with procurement, calibration, and maintenance of equipment/systems.Ensure all documentation is accurate, complete, and compliant.Respond promptly to manufacturing and QA validation support requests.Foster a collaborative and positive team environment.QualificationsBachelor’s degree in Engineering or Biological Sciences.Minimum 2 years of experience in validation and quality assurance within the pharmaceutical industry.At least 1 year of direct experience in equipment, utility, and facility qualification.Proficient in GAMP 5 systems and 21 CFR Part 11 compliance.Strong understanding of US and EU/MHRA data integrity guidance.Excellent communication skills and ability to work cross-functionally in a fast-paced environment.Physical RequirementsAbility to lift, carry, push, or pull up to 50 lbs occasionally using a hand truck.Capable of performing repairs involving cutting, brazing, TIG/MIG or stick welding.Must be able to work both indoors and outdoors.Physically capable of climbing ladders, working overhead, and in lying positions.Must be able to wear appropriate PPE including various types of respirators (APR, SAR).

Pay and Benefits

The pay range for this position is $40.00 - $48.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Plainview,NY.

Application Deadline

This position is anticipated to close on Aug 25, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Por favor confirme su dirección de correo electrónico: Send Email