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 role provides quality assurance guidance and support to ensure process, data, and product quality in a cGMP-regulated pharmaceutical manufacturing environment. Initially, the position supports facility start-up activities, including batch record and supporting CGMP documentation review. It provides quality support to Manufacturing, Materials Management, Facilities, and other site functions by reviewing and approving quality-related documentation, supporting materials receipt and movement, and helping ensure compliance with procedures, regulatory requirements, and quality standards. The role also supports validation, change control, nonconformance investigations, CAPA, and continuous improvement activities. It collaborates with cross-functional teams to promote operational readiness and ongoing compliance, and maintains accurate records in electronic quality systems, SAP, LIMS, and related business systems. The role requires working day shift for 3–6 months during training; the job is listed as a night position, with the listed shift also identified as day.
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 review 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 established procedures, regulatory requirements, and quality standards.
- Review and approve quality-related documentation for Manufacturing, Materials Management, and other site functions.
- Partner with Materials Management to support 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 ensure operational readiness and ongoing compliance.
- Maintain accurate documentation within electronic quality systems and support quality processes using SAP, LIMS, and related business systems.
Benefits
- Eligibility for bonus, stock, and benefits.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
