Science, Quality & Engineering Professionals

Job Summary:

The Science, Quality & Engineering Professional supports scientific, quality assurance, compliance and engineering activities to ensure products, processes and systems meet applicable regulatory, quality and business requirements. This role participates in cross-functional projects, process improvements, investigations, validations, and continuous improvement initiatives while maintaining compliance with company procedures and industry standards.

Responsibilities:

• Support quality systems and engineering processes in compliance with applicable regulations, standards, and company procedures.
• Participate in investigations related to nonconformances, deviations, complaints, CAPAs, and quality events.
• Review and analyze technical documentation, batch records, protocols, reports, and quality records.
• Assist in risk assessments and root cause analysis activities.
• Support the development, revision, and implementation of Standard Operating Procedures (SOPs), work instructions, and technical documents.
• Collaborate with cross-functional teams to implement process improvements and operational excellence initiatives.
• Participate in validation and qualification activities for equipment, systems, utilities, and processes.
• Monitor and analyze process performance metrics, trends, and quality indicators.
• Support change control activities, including documentation review and implementation.
• Ensure compliance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and applicable regulatory requirements.
• Assist during internal, customer, and regulatory audits.
• Prepare technical reports, data summaries, and presentations.
• Utilize quality and business systems for documentation management, data analysis, and project tracking.
• Support product lifecycle activities and continuous improvement projects.

Qualifications:

• Bachelor's Degree in Engineering, Biological Sciences, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences, Life Sciences, or related technical field.
• Advanced degree is a plus.
• Experience in Quality, Engineering, Manufacturing, Validation, Regulatory Affairs, Laboratory Operations, or related technical functions.
• Experience working in regulated environments is preferred.
• Knowledge of quality systems and regulatory requirements.
• Understanding of GMP, GDP, ISO, FDA, MDR, or other applicable industry regulations.
• Strong analytical and problem-solving skills.
• Experience with investigations, risk management, and continuous improvement methodologies.
• Ability to interpret technical and scientific data.
• Strong written and verbal communication skills.
• Proficiency in Microsoft Office applications and electronic quality management systems.
• Ability to work independently and in cross-functional team environments.
• Strong organizational and documentation skills.
• Project management skills.
• Root Cause Analysis tools.
• Risk Management methodologies.
• Validation and qualification processes.
• Statistical analysis and data trending.
• Lean Manufacturing and Continuous Improvement principles.
• Audit readiness and compliance support.
• May work in laboratory, manufacturing, office, or regulated production environments.
• May require participation in audits, inspections, training sessions, and cross-functional meetings.
• Ability to manage multiple priorities while maintaining quality and compliance standards.

Available:

Work Type: Contract, Temporary, Professional Services

Location: On-Site

Work Location: In person