Position SummaryThe Quality Engineer is responsible for supporting and maintaining quality systems within a pharmacy environment, with a strong focus on equipment qualification, process validation, environmental monitoring, and cold chain quality oversight. The ideal candidate has hands-on experience with IQ/OQ/PQ, process validation, environmental monitoring, and cold chain shipping in regulated and distribution operations, and is comfortable driving investigations, risk assessments, CAPAs, and continuous improvement activities.
Key Responsibilities - Support and oversee qualification and validation activities for facilities, utilities, equipment, and dispensing processes in accordance with regulatory requirements.
- Define validation scope, approach, responsibilities, acceptance criteria, and requalification/revalidation strategy for facilities, utilities, equipment, processes, and computerized systems as applicable.
- Develop, review, execute, and approve validation lifecycle documentation, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and process validation protocols and reports.
- Ensure qualification and validation activities are scientifically sound, risk-based, and compliant with internal procedures and regulatory expectations.
- Support ongoing process validation and continued process verification activities through data collection, trending, and analysis.
- Review and trend process performance data to identify risks, deviations, and opportunities for improvement.
- Manage or support the environmental monitoring program for classified or controlled manufacturing areas, including viable and non-viable monitoring review, trending, excursion assessment, and follow-up actions.
- Investigate environmental monitoring excursions, nonconformances, and deviations, support root cause analysis and effectiveness checks for corrective and preventive actions.
- Author, review, and revise SOPs, work instructions, protocols, and technical reports related to quality engineering, validation, monitoring, and distribution quality activities.
- Participate in change control assessments related to equipment, processes, manufacturing areas, utilities, monitoring systems, and distribution processes.
- Partner with the Gifthealth Supply Chain team to support quality requirements for storage, handling, packaging, and distribution of temperature-sensitive materials and products.
- Provide quality oversight for cold chain shipping processes, including shipper qualification, packaging configuration review, temperature monitoring requirements, lane assessments, and excursion management.
- Support development, implementation, and continuous improvement of procedures and controls for cold chain distribution to ensure product quality and compliance are maintained throughout transport.
- Review and assess temperature excursion events, support investigations, perform risk assessments, and help define appropriate corrective and preventive actions.
- Collaborate with internal stakeholders and external logistics partners to ensure compliant cold chain practices and documentation.
- Support internal and external audits and regulatory inspections by providing documentation, technical rationale, and subject matter expertise.
- Collaborate with site teams to ensure compliance with GMP, data integrity, contamination control, quality risk management principles, and applicable distribution requirements.
- Drive continuous improvement initiatives that enhance product quality, process robustness, distribution reliability, and operational compliance.
Qualifications- Education: Bachelor's degree in engineering, Quality, Microbiology, Chemistry, Lifesciences, or a related technical field.
- Experience: 3-7 years of experience in a regulated environment
- Skills:
- Demonstrated experience with IQ/OQ/PQ for equipment, systems, and/or facilities.
- Strong experience in process validation and with automated equipment within a regulated manufacturing setting.
- Hands-on experience supporting or managing environmental monitoring programs in controlled environments.
- Experience supporting cold chain shipping, storage, and distribution quality activities, preferably for temperature-sensitive pharmaceutical or healthcare products.
- Working knowledge of regulations and guidance applicable to manufacturing, validation, and distribution activities.
- Experience with deviation investigations, CAPA, change control, and risk assessments.
- Strong technical writing skills, with experience authoring protocols, reports, validation documents, and quality procedures.
- Ability to analyze data, identify trends, and make sound quality-based decisions.
- Strong communication and cross-functional collaboration skills.
Work Environment- Location: [On-site]
- Schedule: [Full-time]
- Ability to work in a manufacturing environment, including controlled or classified areas.
- May require gowning and adherence to cleanroom procedures.
- Ability to stand, walk, and perform routine site-based activities as needed.
Salary Description
88,000-120,000
