Quality Validation Engineer / Validation Specialist/Quality Manager III

Pyramid Consulting, Inc; Swiftwater (Monroe County); On-site; USD 96,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid sick leave

Job summary

Pyramid Consulting, Inc. has an immediate need for a Quality Validation Engineer / Validation Specialist/Quality Manager III in Swiftwater, PA.

This 12+ month contract requires strong expertise in validation, CAPA, and regulatory compliance to support life sciences manufacturing. You will collaborate with Quality, Manufacturing, Engineering and Regulatory Affairs to ensure QSR/GxP adherence, lead CAPA investigations, and deliver robust technical documentation and reporting across equipment,

Qualifications

• Bachelor's degree in engineering, life sciences, or related technical discipline.
• 6–9 years in pharmaceutical, biopharmaceutical, or other regulated manufacturing.
• Strong background in quality validation, quality systems, and regulatory compliance.
• Experience leading CAPA investigations and activities.
• Knowledge of QSR, GxP requirements, and industry best practices.
• Experience supporting validation activities for equipment, processes, facilities, and computerized systems.

Responsibilities

• Lead CAPA investigations and activities.
• Support validation activities for equipment, processes, facilities, and computerised systems.
• Collaborate with Quality, Manufacturing, Engineering, Validation and Regulatory Affairs.
• Prepare and maintain technical documentation and reports.
• Ensure compliance with FDA, GMP, GxP, and QSR requirements.

Skills

Quality Validation

CAPA Management

Regulatory Knowledge

Cross-Functional Collaboration

Project Management

Technical Documentation

Continuous Improvement

Education

Bachelor's degree in Engineering/Life Sciences

Master's degree preferred

Job description

Immediate need for a talented Quality Validation Engineer / Validation Specialist/Quality Manager III. This is a 12+ Months Contract opportunity with long-term potential and is located in Swiftwater, PA (Onsite).

Job ID:26-26881

Pay Range: $70 - $80/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Requirements and Technology Experience:

• Skills- Quality Validation & Compliance
• CAPA Management
• Regulatory Knowledge (FDA, GMP, GxP, QSR)
• Cross-Functional Collaboration
• Project Management
• Technical Documentation & Reporting
• Continuous Improvement & Quality Excellence Bachelor's degree in Engineering, Life Sciences, or a related technical discipline required; Master's degree preferred.
• 6-9 years of experience in the pharmaceutical, biopharmaceutical, or other highly regulated manufacturing environments.
• Strong background in quality validation, quality systems, and regulatory compliance within the life sciences industry.
• Demonstrated experience leading and managing Corrective and Preventive Action (CAPA) investigations and activities.
• Comprehensive knowledge of Quality System Regulations (QSR), GxP requirements, and industry best practices.
• Experience supporting validation activities, including equipment, process, facility, computerized systems, and documentation review.
• Preferred experience in high-speed aseptic filling operations and sterile manufacturing environments.
• Proven ability to collaborate effectively with cross-functional teams, including Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Strong analytical and problem-solving skills with exceptional attention to detail.
• Ability to manage multiple projects simultaneously while meeting aggressive timelines and strict deadlines.
• Excellent verbal and written communication skills, with the ability to present complex information clearly to diverse stakeholders.
• Self-motivated, organized, and capable of working independently in a fast-paced, regulated environment.

Our client is a leading Healthcare Industry and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.