Manufacturing Quality Engineer (Nights)
About The Position
The Manufacturing Quality Engineer, Associate will support the Endeavor Project, a strategic initiative focused on starting up and preparing a new oligonucleotide manufacturing facility for operations. The position provides quality assurance guidance and support to ensure process, data, and product quality in a cGMP-regulated pharmaceutical manufacturing environment. The role supports batch-record and CGMP-documentation reviews, quality-related documentation approvals, materials handling, facility activities, validation, change control, investigations, CAPAs, and continuous improvement. It works with Manufacturing, Quality Control, Materials Management, Facilities, Utilities, and Pest Control to support operational readiness and ongoing compliance, and maintains records using electronic quality systems and related business tools. The position requires working day shift for 3–6 months during training; the listed role is for nights thereafter.
Requirements
- Bachelor's degree in a scientific, engineering, or related field, or an equivalent combination of education and experience.
- At least 2 years of Quality Assurance experience in a cGMP-regulated environment.
- Experience performing batch-record reviews and reviewing 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.
- Ability to work day shift for 3–6 months during training.
Nice To Haves
- Experience supporting pharmaceutical or biopharmaceutical manufacturing operations.
- Experience with SAP, LIMS, or BMRAM systems.
- Experience supporting Shipping & Receiving, Materials Management, and Facilities functions.
- Experience supporting start-up, commissioning, qualification, or validation activities.
Responsibilities
- Provide quality assurance guidance, expertise, and support to ensure process, data, and product quality in a cGMP-regulated pharmaceutical manufacturing environment.
- Support start-up activities for a new oligonucleotide production facility.
- Review batch records and supporting CGMP documentation for compliance with procedures, regulatory requirements, and quality standards.
- Review and approve quality-related documentation for Manufacturing, Materials Management, and other site functions.
- Partner with Materials Management on Shipping & Receiving and the receipt, disposition, and movement of materials in accordance with CGMP requirements.
- Provide quality support for Facilities activities, including reviewing and approving maintenance and facility work orders.
- Support validation activities, change control, nonconformance investigations, CAPA activities, and continuous improvement initiatives.
- Collaborate with Manufacturing, Quality Control, Materials Management, Facilities, Utilities, and Pest Control to support operational readiness and ongoing compliance.
- Maintain accurate documentation in electronic quality systems and support quality processes using SAP, LIMS, and related business systems.
Benefits
- Eligibility for bonus, stock, and benefits.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
