Senior Quality Engineer Specialist - Pharmaceutical jobs in United States
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Zing Recruiting · 1 day ago

Senior Quality Engineer Specialist - Pharmaceutical

Zing Recruiting is a leader in the staffing industry and is seeking a Senior Quality Engineer Specialist for a growing pharmaceutical company. This role involves providing quality oversight for GMP readiness, validating processes, and ensuring compliance with data integrity requirements.

ConsultingHuman ResourcesRecruitingStaffing Agency
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Provide Quality oversight for GMP readiness during facility startup, including equipment, utilities, facilities, and process validation
Review and approve qualification and validation deliverables for DS manufacturing systems
Confirm system readiness by reviewing evidence such as drawings, P&IDs, and turnover packages to verify fitness for intended use
Support development and review of Preventive Maintenance (PM) and calibration programs, including intervals and criticality assessments
Execute and/or lead change controls, risk assessments, and investigations (e.g., FMEA, hazard analysis)
Drive structured problem-solving related to equipment, utilities, facilities, calibrations, and PMs
Ensure compliance with data integrity requirements, 21 CFR Part 11, and ALCOA++ principles
Partner closely with Engineering, Validation, Maintenance, Automation, Manufacturing, and QC teams
Maintain inspection-ready documentation and asset status throughout startup activities
Other duties as assigned

Qualification

GMP complianceQuality EngineeringValidation processesData integrityRisk assessmentsProblem-solvingCollaboration

Required

Bachelor's degree in relevant field
5+ years of experience in GxP regulated environment with a focus on Quality Engineering

Company

Zing Recruiting

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Zing Recruiting is a staffing firm that offers temporary and direct hire services.

H1B Sponsorship

Zing Recruiting has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2022 (6)
2021 (4)
2020 (11)

Funding

Current Stage
Growth Stage
Company data provided by crunchbase