Validation Engineer

Job Description

Job Description

Validation Engineer

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The Validation Engineer ensures that all critical equipment, utilities, and facility systems in a regulated aseptic pharmaceutical environment are fully qualified, validated, and maintained in a consistent state of control. This role supports sterile manufacturing operations by planning and executing validation activities, maintaining robust documentation, and ensuring ongoing inspection readiness. The Validation Engineer works closely with Quality Assurance, Operations, Facilities, and Engineering teams to uphold sterility assurance, compliance with current Good Manufacturing Practices (cGMP), and alignment with FDA 503B guidance and Annex 1 expectations.

Responsibilities

• Plan, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for new and existing equipment, including isolators, cleanroom HVAC systems, bio-safety cabinets, laminar flow hoods, pooling and filling equipment, and environmental monitoring systems.
• Validate and maintain the qualified state of facility utilities such as compressed air, clean steam, water for injection (WFI), HVAC, and differential pressure systems to support aseptic manufacturing.
• Support cleanroom qualification activities, including ISO classification, airflow visualization studies, and recovery testing, to ensure controlled environmental conditions.
• Write, execute, and review validation protocols, reports, and change controls, including those provided by third parties, in accordance with FDA 503B guidance, cGMP, and Annex 1 requirements.
• Maintain validation master plans (VMP), equipment qualification files, and complete lifecycle documentation to demonstrate ongoing control of systems and equipment.
• Ensure all validation activities meet data integrity expectations, including adherence to ALCOA+ principles for accurate, complete, and reliable records.
• Provide validation and qualification support to Quality and Operations teams to ensure equipment and facility conditions consistently support aseptic processing.
• Support aseptic processing studies such as media fills, smoke studies, and contamination control strategy implementation to maintain sterility assurance.
• Participate in investigations related to equipment failures, environmental excursions, or sterility assurance risks, and contribute to root cause analysis and corrective actions.
• Oversee calibration and preventive maintenance schedules for critical equipment to ensure reliable performance and regulatory compliance.
• Ensure vendors and service providers follow GMP standards and provide complete, compliant calibration certificates, preventive maintenance records, and service reports.
• Review and approve calibration certificates, preventive maintenance records, and service reports to verify accuracy and completeness.
• Evaluate equipment and facility changes for potential validation impact and define appropriate qualification or requalification activities.
• Perform risk assessments, including Failure Modes and Effects Analysis (FMEA) and hazard analyses, to support change control decisions and prioritize mitigation actions.
• Ensure requalification activities are completed following equipment modifications, repairs, or deviations to maintain validated status.
• Maintain validation documentation in an audit-ready state to support internal audits and regulatory inspections.
• Support internal audits and FDA inspections by presenting validation evidence, explaining validation strategies, and responding to technical questions.
• Identify gaps in validation and compliance systems and drive continuous improvement initiatives to enhance robustness, efficiency, and regulatory alignment.
• Collaborate cross-functionally with Quality Assurance, Operations, Facilities, and Engineering to align validation activities with production needs and regulatory expectations.

Essential Skills

• Proven experience planning, executing, and documenting IQ/OQ/PQ for equipment such as isolators, cleanroom HVAC, bio-safety cabinets, laminar flow hoods, and sterile filling equipment.
• Hands-on experience with equipment qualification, cleanroom validation, and aseptic processing support in a regulated pharmaceutical environment.
• Experience overseeing equipment calibration programs and preventive maintenance schedules for critical systems.
• Strong understanding of cGMP requirements and practical experience applying them in aseptic pharmaceutical manufacturing.
• Demonstrated familiarity with FDA 503B guidance and Annex 1 expectations for sterile manufacturing.
• Experience supporting or conducting media fills, smoke studies, and contamination control strategy activities.
• Experience with risk assessment methodologies such as FMEA and hazard analysis in support of change control.
• Investigator training and experience writing clear, structured investigation reports.
• Experience reviewing batch records, manufacturing documentation, or Quality Assurance compliance records.
• Knowledge of data integrity principles and ALCOA+ expectations for validation and quality documentation.
• Excellent technical writing skills with the ability to produce clear, compliant validation protocols, reports, and lifecycle documentation.
• Strong problem-solving skills and the ability to analyze complex technical issues and propose practical, compliant solutions.
• Ability to work effectively in a fast-paced, highly regulated environment and collaborate across multiple functions.
• 3–5 years of Quality Assurance or related experience in aseptic pharmaceutical manufacturing.
• 1 to 5 years of experience in aseptic pharmaceutical manufacturing, preferably in a 503B outsourcing or sterile injectable environment.
• Bachelor’s degree in Engineering, Life Sciences, or a related technical field.

Additional Skills & Qualifications

• Bachelor’s degree in a science discipline, Engineering, Life Sciences, or a related technical field.
• Experience working in or with 503B outsourcing facilities or sterile injectable manufacturing operations.
• Understanding of USP <797> , USP <800> , and USP <825> requirements as they relate to sterile compounding and handling.
• Familiarity with calibration systems, maintenance programs, and equipment lifecycle management processes.
• Experience with internal audits and external inspections, including preparation of validation documentation and responses to technical questions.
• Ability to identify process and system gaps and contribute to continuous improvement initiatives in validation and compliance.
• Comfort with flexible job titles and responsibilities in a growing, evolving organization.
• Motivation to grow with a rapidly expanding startup and pursue advancement opportunities as the organization scales.

Work Environment

The role is based in a highly regulated aseptic pharmaceutical manufacturing environment that operates as an FDA-registered 503B outsourcing facility specializing in sterile compounded medications for critical care settings. The facility runs under strict current Good Manufacturing Practices (cGMP) and is subject to ongoing regulatory oversight. You will work closely with Quality Assurance, Operations, Facilities, and Engineering teams in cleanroom and support areas, focusing on equipment qualification, utilities, and facility systems that support sterile production. The environment emphasizes sterility assurance, robust documentation, and continuous inspection readiness, including preparation for FDA inspections and internal audits. The organization is a growing startup with plans for rapid expansion into multiple locations, offering flexible job titles, opportunities for advancement, and a culture that values top-tier technical talent and high performance.

This is a Permanent position based out of Colonie, NY.

The pay range for this position is $50.00 - $70.00/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)

This is a fully onsite position in Colonie,NY.

This position is anticipated to close on Aug 10, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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 process due to a disability, please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.