Validation Engineer III

Amneal

2d

About The Position

The Validation Engineer III drafts and implements Quality System documentation, including SOPs and Traceability Matrices, to establish good validation practices. The role authors and executes URS, IQ, OQ, and PQ protocols in accordance with GDP guidelines and internal quality standards; coordinates validation activities with vendors; analyzes and assembles results; and drafts validation reports.

The position provides input on user and functional requirements for current and future processing equipment, develops appropriate documentation, and interfaces with Contract Manufacturers to ensure relevant requirements are met. It also supports staff in R&D and Manufacturing with technology transfer and continuous improvement. The engineer is expected to complete assigned duties on time, proactively communicate delays and other issues to the validation manager and relevant stakeholders, and comply with regulatory, corporate, and Quality System policies.

The role requires travel as needed, estimated at 20%–30%, and the ability to lift at least 25 pounds. The salary range is $103,000–$115,000 per year. The position also offers a short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months. Eligible positions receive access to a flexible benefits program, including health and insurance benefits, a significant 401(k) matching contribution, and employee well-being programs.

Requirements

• Degree in engineering, pharmaceuticals, or another relevant discipline.
• At least 5 years of experience in a medical device environment or another FDA-regulated environment.
• Experience with design documentation, including URS, FRS, DS, and other engineering specifications.
• Experience with validation, including IQ, OQ, PQ, PV, CSV, and MVP.
• Experience with Quality Systems, including Change Control, Non-Conformances, and Requalification.
• Understanding of cGxP principles and familiarity with ISO guidelines.
• Working knowledge of the Computer Systems Validation lifecycle and documentation.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to work independently with adequate supervision, multitask, and support several projects simultaneously.
• Strong communication, interpersonal, and teamwork skills.
• Strong technical writing and presentation skills.
• Ability to lift at least 25 pounds.
• Ability to travel as needed, estimated at 20%–30%.

Nice To Haves

• Experience with biological products is highly desirable.

Responsibilities

• Draft and implement Quality System documentation, including SOPs and Traceability Matrices, to establish good validation practices.
• Author and execute URS, IQ, OQ, and PQ protocols in compliance with GDP guidelines and internal quality standards.
• Coordinate validation activities with vendors, analyze and assemble results, and draft validation reports.
• Provide input on user and functional requirements for current and future processing equipment and draft appropriate documentation.
• Interface with Contract Manufacturers to ensure relevant user and functional requirements are met.
• Support non-engineering staff, including R&D and Manufacturing, to facilitate technology transfer and continuous improvement.
• Complete assigned duties on time and proactively communicate delays and other issues to the validation manager and relevant stakeholders.
• Comply with regulatory, corporate, and Quality System policies.

Benefits

• Short-term incentive opportunity, such as a bonus or performance-based award, within the first 12 months.
• Flexible benefits program for eligible positions.
• Health and insurance benefits.
• Significant 401(k) matching contribution.
• Employee well-being programs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level