Manufacturing Quality Engineer (Nights)

Job Description

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.

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.

Qualifications

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.

 

Additional Details

This job has a full time weekly schedule. Applications for this job will be accepted until at least October 26, 2026 or until the job is no longer posted.

The full-time equivalent pay range for this position is $67,760.00 - $105,875.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email [email protected] or contact +1-262-754-5030. For more information about equal employment opportunity protections, please visit www.agilent.com/en/accessibility.

Travel Required:

No

Shift:

Day

Duration:

No End Date

Job Function:

Quality/Regulatory