Amneal Pharmaceuticals · 1 hour ago
Senior Validation Engineer
Piscataway, NJ
Full-time
Onsite
Senior Level
5+ years expAmneal Pharmaceuticals is seeking a Senior Validation Engineer to perform validation and engineering activities while monitoring and improving pharmaceutical systems and processes. The role involves designing validation documents, managing GMP documentation, and collaborating with management and vendors.
ManufacturingMedicalPharmaceutical
Responsibilities
Design, develop and execute validation documents, define validation strategy
Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ) for equipment/utilities/facilities and generate reports which summarize results, specification and its acceptance criteria
Prepare and review various documents using QUMAS software.Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, initiation and review of change controls
Develops User Requirements Specification (URS) and Design Specifications
Oversee the collection of equipment manuals from vendors and other required documents as well as Factory Acceptance Test (FAT) execution
Design and develop test strategy and methodology for the validation of complex equipment
Manage GMP documentation by supporting cGMP programs including: Risk Analysis, Change Control, and Standard Operating Procedure and Notice of Investigation (NOI)/Corrective Action and Preventative Action (CAPA)
Partner with management, technical peers, and negotiate with vendors to gain consensus on design, testing and methodology
Develops/updates operational and engineering related standard operating procedures to comply with cGMP and regulatory requirements
Assist with Engineering projects as needed
Supervise and train staff as needed
Perform other duties as assigned
Qualification
Required
Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required
5 years or more in 5 or more years relevant experience in Engineering, pharmaceutical industry, cGMP environment with bachelors
Proficient in MS Office. - Advanced
Excellent technical writing skills. - Advanced
Excellent oral and written communication skills. - Advanced
Must be able for follow direction and execute assigned work independently, after initial training is completed. - Advanced
Ability to work both independently and in conjunction with a team - Advanced
Knowledge of Good Documentation Practices, Engineering Qualification Procedures a must. Reads, understands and verifies piping & instrument diagram, engineering layout, drawing and documents
Company
Amneal Pharmaceuticals
Amneal Pharmaceuticals manufactures, markets and/or distributes more than 88 drugs in the United States.
5001-10000 employees
H1B Sponsorship
Amneal Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (32)
2023 (33)
2022 (33)
2021 (42)
2020 (34)
Funding
Current Stage
Public CompanyTotal Funding
$3.2B2023-11-16Post Ipo Debt· $2.35B
2018-05-07IPO
2017-10-01Post Ipo Equity· $854M
Leadership Team
Chirag Patel
President & Co-Chief Executive Officer
Recent News
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