Manufacturing Quality Engineer (Nights)
Agilent Technologies
Summary
The Manufacturing Quality Engineer, Associate will support the Endeavor Project, a strategic initiative focused on the start-up and operational readiness of a new oligonucleotide manufacturing facility.
Job description
Responsibilities
- Provides quality assurance guidance, expertise, and support to ensure process, data, and product quality within a cGMP-regulated pharmaceutical manufacturing environment.
- Initially supports start-up activities for a new oligonucleotide production facility. Performs batch record review and review of supporting CGMP documentation to ensure compliance with established procedures, regulatory requirements, and quality standards.
- Supports Manufacturing, Materials Management, and other site functions by reviewing and approving quality-related documentation. Partners with Materials Management to support Shipping & Receiving, and to support the receipt, disposition, and movement of materials in accordance with CGMP requirements.
- Provides quality support for Facilities activities, including review and approval of maintenance and facility work orders. Supports validation activities, change control, nonconformance investigations, CAPA activities, and continuous improvement initiatives.
- Collaborates with cross-functional teams including Manufacturing, Quality Control, Materials Management, Facilities, Utilities, and Pest Control to ensure operational readiness and ongoing compliance.
- Maintains accurate documentation within electronic quality systems and supports quality processes utilizing SAP, LIMS, and related business systems.
Minimum Qualifications
- Bachelor's degree in a scientific, engineering, or related field, or an equivalent combination of education and experience.
- Minimum of 2 years of Quality Assurance experience in a cGMP-regulated environment.
- Experience performing batch record review and review of GMP documentation.
- Working knowledge of quality systems including deviations, CAPAs, change controls, and document management.
- Experience supporting cross-functional operations in a regulated manufacturing environment.
- Strong attention to detail, communication, and problem-solving skills.
- Must be able to work on day shift for 3-6 months during training.
Preferred Qualifications
- Experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
- Experience with SAP, LIMS, BMRAM systems.
- Experience supporting Shipping & Receiving, Materials Management, and Facilities functions.
- Experience supporting start-up, commissioning, qualification, or validation activities.
Requirements
- Bachelor's degree in a scientific, engineering, or related field, or equivalent combination of education and experience
- Minimum of 2 years of Quality Assurance experience in a cGMP-regulated environment
- Experience performing batch record review and review of GMP documentation
- Working knowledge of quality systems including deviations, CAPAs, change controls, and document management
- Experience supporting cross-functional operations in a regulated manufacturing environment
- Strong attention to detail, communication, and problem-solving skills
- Must be able to work on day shift for 3-6 months during training
Benefits
- Bonus
- Stock
- Benefits
Company overview
Agilent Technologies is a global leader in life sciences, diagnostics, and applied markets, delivering innovative solutions that advance scientific discovery and improve quality of life. Founded in 1999 as a spin-off from Hewlett-Packard, the company has grown into a major player in analytical instrumentation and laboratory services. With approximately 18,000 employees worldwide and annual revenues exceeding $6.5 billion, Agilent provides a comprehensive portfolio of instruments, software, services, and consumables that serve laboratories across pharmaceutical, biotechnology, clinical diagnostics, environmental, food safety, and academic research sectors. The company's product offerings span chromatography systems, mass spectrometry, spectroscopy, cell analysis platforms, molecular diagnostics, and laboratory informatics solutions. Agilent's expertise extends beyond hardware to include comprehensive laboratory management services through its CrossLab division, which helps customers optimize laboratory operations, ensure regulatory compliance, and maximize research productivity. The company's commitment to innovation and customer support has made it a trusted partner for scientists and researchers worldwide who rely on Agilent's technologies to address complex analytical challenges and drive scientific breakthroughs.