Analysis Skills, Automation, Biology, Biotech and Pharmaceutical, Continuous Improvement, Cross-Functional, Current Good Manufacturing Practice (cGMP), Documentation, Equipment Maintenance/Repair, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Maintain Compliance, Manufacturing, Medical Equipment, Problem Solving Skills, Process Engineering, Process Improvement, Process Validation, Quality Assurance, Regulations, Regulatory Compliance, Risk Analysis, Safety/Work Safety, Strategic Planning, Systems Maintenance, Technical Writing, Traceability, Training/Teaching, Writing Skills
Pay range for this position is $39/hr-$42/hr, - Depending on experience
Experience: 1-3 years of experience in a regulated manufacturing environment (medical devices, pharma, or biotech, preferably FDA)
Responsibilities
Develops, prepares, and executes IQ, OQ, and PQ protocols and reports for equipment/systems.
Conducts risk assessments and develops qualification strategies for new and existing equipment/systems.
Analyzes and interprets qualification data, ensuring accuracy, completeness, and adherence to regulatory and internal requirements.
Collaborates with cross-functional teams, including Process Engineering, Automation Maintenance Support, Design Transfer Operations, Manufacturing, Quality, Facilities, and Safety Health and Environment (SHE), to ensure seamless execution of qualification activities and successful achievement of qualification-related project milestones.
Participates in process optimization and continuous improvement initiatives to enhance quality and efficiency.
Ensures compliance with FDA, ISO, and other relevant regulatory guidelines, as well as adherence to internal requirements.
Provides training and guidance to manufacturing and quality personnel on qualification processes and procedures.
Maintains equipment/systems qualification documentation and ensures traceability and accessibility for audits and inspections.
Other duties as assigned by management.
Qualifications
Bachelor's Degree in Engineering or Life Science.
Strong technical writing, analytical, and problem-solving skills.
Knowledge of cGMP and regulatory standards.
Demonstrated experience assisting with or supporting qualification activities within the medical device, pharmaceutical, or biotechnology industry is required.
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Apollo Professional Solutions
Apollo Professional Solutions was founded by Gayle A. Williams in 1983 as a technical staffing firm supporting New England aerospace companies. Today, Apollo has grown into a $40 million year company, with 5 regional offices nationwide that offers diversified support to industries that include: defense, military, aeronautical, civil, food & beverage, healthcare, marine, pharmaceutical and scientific industries, as well as local government. We are an equal opportunity employers, that is also certified as a Women’s Business Enterprise by WBENC as well as the State of Massachusetts (SOWMBA Office.)