Senior Compliance Engineer, Equipment Validation & ECQ

Bristol Myers Squibb

Summit (NJ)

On-site

USD 107,000 - 129,000

Full time

4 days ago

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Benefits offered by this job

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Retirement & Insurance

Job summary

Bristol Myers Squibb is seeking a Principal Compliance Engineer, ECQ in Summit, NJ to lead equipment commissioning and qualification activities within a regulated environment. The role requires ensuring compliance with USP/EP/J and FDA guidelines, performing gap analyses, and driving projects to maintain validated status.

The candidate should have a BS in engineering/science and 5+ years in FDA-regulated settings, with strong communication and documentation skills to interact with

Qualifications

BS in engineering or science required.
Minimum 5 years’ experience in an FDA-regulated industry.
2 years’ experience in a quality assurance-related discipline preferred.
Regulatory guidelines knowledge (FDA, EMA, USP, EP, JP).
Strong verbal and written communication skills; able to work independently.

Responsibilities

Ensure equipment compliance with local, global, and regulatory guidelines.
Review and revise departmental procedures to maintain compliance.
Lead or support ECQ department projects of varying complexity.
Assist with internal and external audits and regulatory reviews.

Skills

cGMP/GXP/21CFR11

Regulatory knowledge

Documentation skills

Communication skills

MS Office + data systems

Education

BS in Engineering/Science

Tools

Microsoft Office

Database systems

Job description

The candidate should have a BS in engineering/science and 5+ years in FDA-regulated settings, with strong communication and documentation skills to interact with

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