Novartis
Equipment Qualification Engineer
We are seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols (IQ/OQ/PQ), preparing documentation, and ensuring equipment is fit for its intended use in a pharmaceutical quality control environment. Key Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and compliant equipment qualification. Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation. Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines. Support investigations and deviations related to equipment performance. Assist in change control processes related to equipment upgrades or replacements. Maintain traceability and data integrity throughout the qualification lifecycle. Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field. Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment. Strong understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP). Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment. Proficiency in writing and reviewing technical documentation. Excellent organizational and communication skills. Preferred Skills
Experience with computer system validation (CSV) and data integrity principles. Ability to work independently and manage multiple priorities. Location
Millburn, NJ (Onsite) Pay Rate
$55 - $58/hour based on experience and qualifications (W2 Only) Contract
8-month Benefits
Health, dental, vision, 401k Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
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We are seeking a detail-oriented and experienced Equipment Qualification Contractor to support the qualification of laboratory equipment in compliance with cGMP and regulatory standards. The contractor will be responsible for executing qualification protocols (IQ/OQ/PQ), preparing documentation, and ensuring equipment is fit for its intended use in a pharmaceutical quality control environment. Key Responsibilities
Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Collaborate with cross-functional teams (QC, QA, Engineering, Validation) to ensure timely and compliant equipment qualification. Prepare and maintain User Requirement Specifications (URS) and Design Qualification (DQ) documentation. Ensure all qualification activities are documented accurately and meet FDA, EMA, and ICH guidelines. Support investigations and deviations related to equipment performance. Assist in change control processes related to equipment upgrades or replacements. Maintain traceability and data integrity throughout the qualification lifecycle. Qualifications
Bachelor’s degree in Engineering, Life Sciences, or related field. Minimum 3 years of experience in equipment qualification within a GMP-regulated pharmaceutical or biotech environment. Strong understanding of Good Manufacturing Practices (GMP) and Good Engineering Practices (GEP). Experience with laboratory instruments (e.g., HPLC, GC, incubators, autoclaves) and manufacturing equipment. Proficiency in writing and reviewing technical documentation. Excellent organizational and communication skills. Preferred Skills
Experience with computer system validation (CSV) and data integrity principles. Ability to work independently and manage multiple priorities. Location
Millburn, NJ (Onsite) Pay Rate
$55 - $58/hour based on experience and qualifications (W2 Only) Contract
8-month Benefits
Health, dental, vision, 401k Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. Accommodation
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.
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