Validation Engineer

The ideal candidate will have expertise in environmental monitoring, protocol generation,

execution of qualification activities, and documentation updates. Experience with room

environmental monitoring equipment Installation, Operational and Performance

Qualification (IOPQ), aseptic gowning, and cleaning validation is highly desirable.

Key Responsibilities:

Perform room qualification activities including temperature mapping, environmental monitoring (differential pressures, particulate monitoring, etc.), and other activities

associated with facility qualification.

Qualification of equipment such as autoclaves and chambers (temperature mapping, cycle development, etc.).

Generate protocols, summary reports, and protocol exceptions for validation activities.

Schedule and execute qualification activities according to project timelines.

Collect and analyze qualification data against acceptance criteria.

Update documentation including Standard Operating Procedures (SOPs), forms, and other relevant documents.

Attend meetings and coordinate projects with cross-functional teams.

Preferred Experience:

Validation Engineer with 4-6 years of experience in a regulated industry.

Experience in room environmental monitoring qualification.

Proficiency in executing equipment IOPQ protocols (e.g., autoclaves, chambers, etc.).

Aseptic gowning experience is a plus.

Knowledge of cleaning validation processes is preferred.

Strong report writing skills.

Qualifications:

Bachelor's degree in Engineering or related field; Master's degree preferred.

2-5 years of experience in validation engineering or related field.

Knowledge of regulatory requirements, including FDA and ISO standards.

Excellent communication and coordination skills.

Ability to work effectively in a cross-functional team environment.

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