Senior Validation Specialist

Integrated Resources, Inc ( IRI ); Swiftwater (Monroe County); On-site; USD 110,000 - 140,000; Full time

Job summary

Integrated Resources, Inc (IRI) is seeking a highly skilled quality and validation professional for a fast-paced, regulated life sciences manufacturing environment in Swiftwater, PA. This role ensures all manufacturing processes, equipment, facilities, and systems meet quality, compliance, and regulatory integrity.

The ideal candidate has deep expertise in quality systems, validation methodologies, CAPA management, and regulatory knowledge (FDA, GMP, GxP).

Qualifications

• 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.
• Quality Validation & Compliance
• CAPA Management
• Regulatory Knowledge (FDA, GMP, GxP, QSR)
• Cross-Functional Collaboration
• Project Management
• Technical Documentation & Reporting
• Continuous Improvement & Quality Excellence

Skills

Quality systems

Validation methodologies

CAPA investigations

Regulatory compliance

QSR/GxP knowledge

Cross-functional collaboration

Project management

Documentation & reporting

Analytical thinking

Attention to detail

Communication skills

Education

Bachelor's degree in Engineering, Life Sciences, or a related technical discipline

Master's degree preferred

Job description

• We are seeking a highly skilled and experienced quality and validation professional to join a dynamic team within a fast-paced, regulated life sciences manufacturing environment.


• This role is central to ensuring that all manufacturing processes, equipment, facilities, and systems meet the highest standards of quality, compliance, and regulatory integrity.


• The ideal candidate brings deep expertise in quality systems, validation methodologies, and regulatory frameworks, and thrives in a collaborative, cross-functional setting where precision, accountability, and continuous improvement are paramount.

Qualifications & Experience:

• 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.


• Quality Validation & Compliance


• CAPA Management


• Regulatory Knowledge (FDA, GMP, GxP, QSR)


• Cross-Functional Collaboration


• Project Management


• Technical Documentation & Reporting


• Continuous Improvement & Quality Excellence