Job Description

Description:

The Senior Validation Engineer is responsible for leading the installation, upgrade, and integration of manufacturing and packaging equipment within the sterile facility, ensuring all systems meet design specifications and operational requirements. This role will oversee and execute qualification activities, including FAT, SAT, IQ, OQ, and PQ while managing project timelines, budgets, and resources to ensure successful and timely completion of engineering initiatives.

Essential Functions:

• Lead manufacturing and packaging equipment installation/upgrades projects for sterile operations. Develop project scopes, technical plans, feasibility analysis, risk assessments, budgets, and execute aligned with business requirements. Coordinate activities related to procurement and contract management and manage maintenance activities by executing and tracking in accordance with organization SOPs.
• Lead qualification activities, including factory acceptance test (FAT), site acceptance test (SAT), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for manufacturing and packaging equipment. Support to develop validation master plan, requalification strategy and environmental monitoring performance qualification (EMPQ). Manage requalification activities per schedule and requirements. Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.
• Oversee and maintain manufacturing and packaging equipment to ensure optimal performance and efficiency. Lead the development of training materials to support maintenance training program and improvizes the facility maintenance program to optimize its costs, compliance and effectiveness.
• Execute new and revised SOPs, ensuring accuracy, compliance, and timely implementation. Lead change control processes and perform thorough impact assessments to evaluate operational, regulatory, and quality implications. Support investigations by identifying root causes, conducting data analysis, and driving effective CAPA implementation to prevent recurrence and enhance system performance.
• Monitor facility operations to ensure full compliance with all applicable local regulatory requirements, including those enforced by the fire department, building department, and public health authorities. Proactively identify compliance risks and ensure corrective actions are implemented to maintain a safe and compliant operating environment.

Additional Responsibilities:

• Maintain engineering documents such as layouts, spare/parts materials, design for maintainability. Verify and develop P&ID, engineering layout, engineering drawings and engineering documents. Assists activities for qualification of the facilities and utilities.

Qualifications

Education:

• Bachelors Degree (BA/BS) Engineering, Manufacturing, or a related field - Required
• Master Degree (MS/MA) Engineering, Manufacturing, or a related field - Preferred

Experience:

• 5 years or more in Experience in validation role within a GMP manufacturing environment/Life science with sterile/aseptic facility.

Specialized Knowledge:

• Strong understanding of cGMP, FDA regulations, and other relevant standards.Proven project management and leadership skills.Exceptional problem-solving and decision-making abilities.Strong communication and interpersonal skills to facilitate collaboration across teams.Proficiency in relevant engineering software and tools.

Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $110,000 to $112,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

About Us

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.