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WhiteCrow Research · 2 days ago

Quality Engineer

Branchburg, NJ

Full-time

Onsite

Senior Level

7+ years exp

WhiteCrow Research is a global talent research and insight specialist, and they are seeking a Quality Engineer to support compliance with cGMP standards in a pharmaceutical manufacturing facility. This role involves reviewing qualification protocols, providing QA support during technical transfers, and ensuring adherence to quality system requirements.

BiotechnologyConsultingEmploymentHuman ResourcesStaffing Agency

Responsibilities

Acting as technical expert and providing QA support during facility, utility, manufacturing equipment, and laboratory instrument qualification by reviewing qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations. Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities

Reviewing and approving qualification protocols and final reports (equipment, utilities, facilities, processes) to ensure alignment with quality and regulatory standards

Supporting execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated

Providing QA support during technical transfer and process validation of new products

Providing support to operation during Change Control and Deviation process

Driving timely and compliant resolution of deviations, non-conformances, and CAPAs arising during operations and qualification activities

Supporting the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations

Maintaining awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations

Providing QA support during regulatory inspection. Participate in internal walkthroughs, and audit

Preparing quality and compliance metrics to support continuous improvements

Qualification

Quality AssuranceCGMP ComplianceValidation PrinciplesFDA GuidelinesEU GuidelinesICH GuidelinesDocument ManagementCommitment to Data IntegrityAttention to DetailCommunication SkillsCollaboration SkillsAdaptability

Required

Bachelor's degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)

Minimum of 7-10 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment

Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity

Experience supporting commissioning and qualification activities

Ability to work collaboratively with operations, engineering, and validation stakeholders

Strong attention to detail and commitment to compliance

Solid written and verbal communication skills

Ability to work collaboratively across departments in a fast-paced environment

Strong knowledge of validation principles and qualification documentation

Proficient in using quality systems and document management tools

Flexible and adaptable to changing priorities and evolving project timelines

Commitment to data integrity, continuous improvement, and patient safety