Senior Equipment Validation Specialist / CQV Engineer (Remote – East Coast USA)

Tap Growth ai; New York (NY); Remote; USD 104,000 - 139,000; Full time

Job summary

A dynamic technology company is seeking a Sr. Equipment and Systems Specialist Contractor to work remotely on the U.S. East Coast. You will manage new instrument deployments, maintenance programs, and ensure compliance with cGMP standards. The ideal candidate has a BSc in Life Sciences or a related field, with a minimum of 4 years of relevant experience and strong interpersonal skills. This role offers a competitive salary between $104,000 and $138,674.

Qualifications

• Minimum of 4 years of experience in a cGMP setting.
• Knowledge of GMP, ICH guidelines, and regulatory requirements is essential.

Responsibilities

• Deploy new instruments to multiple sites.
• Coordinate the qualification and maintenance of instruments.
• Manage multi-site maintenance and audit trail programs.

Skills

Knowledge of equipment lifecycle requirements

Strong interpersonal skills

Flexibility with changing priorities

Self-driven attitude

Education

BSc in Life Sciences, Biotechnology or related subject

Job description

We're Hiring: Sr. Equipment and Systems Specialist!

We are seeking to hire a Sr. Equipment and Systems Specialist Contractor to work remotely on the U.S. East Coast.

Location: New York City, United States
Work Mode: 100% Remote within the U.S. East Coast
Role: Sr. Equipment and Systems Specialist Contractor
Pay Scale: $104,000 - $138,674 (Dependent on Experience)

What You'll Do:

• Carry out the deployment of new instruments to multiple sites
• Oversee and coordinate the qualification and maintenance of instruments
• Create and manage a multi-site maintenance and audit trail program
• Ensure data integrity and proper user management
• Review and assess technical documentation such as vendor IOQs and PQs
• Write equipment lifecycle related documentation such as URS, IQs, OQs and PQs
• Write procedures, deviations, change controls and CAPAs

Job Requirements
Education & Experience:

• Minimum of BSc in Life Sciences, Biotechnology or related subject
• Demonstrated knowledge of equipment lifecycle requirements in a cGMP setting with at least 4 years of experience

General Skills:

• Knowledge and experience with computer system validations is a plus
• Knowledge of GMP, ICH guidelines, pharmacopeia and regulatory requirements
• Strong interpersonal, verbal and written communication skills
• Ability to be flexible with changing priorities
• Self-driven and can-do mindset, without compromising quality

Language Skills:

• Fluent in English

Ready to make an impact? Apply now and let's grow together!