Senior Validation Lead – GMP & Compliance

ThermoFisher Scientific; Allentown (Lehigh County); On-site; USD 110,000 - 150,000; Full time

Job summary

Thermo Fisher Scientific in Allentown, PA is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance across equipment, utilities, facilities, and computer systems.

You will develop validation strategy, mentor a team, and coordinate cross-functional efforts to support cGMP standards and tech transfers in a fast-paced pharmaceutical environment.

Qualifications

• Advanced Degree plus 4 years of validated experience in pharma/biotech manufacturing.
• Bachelor's Degree plus 6 years of validated experience in pharma/biotech manufacturing.
• 3+ years in people management or team leadership.
• Experience with equipment, process, cleaning, computer system, and utility validation.
• Temperature mapping experience preferred.
• Experience with data integrity evaluation and ALCOA++ principles.
• Experience participating in regulatory inspections and customer audits.
• Experience with validation master planning and change control systems.

Responsibilities

• Manage validation activities to ensure product quality and regulatory compliance.
• Develop validation strategy and oversee qualification of equipment, utilities, facilities, computer systems, and manufacturing processes.

Skills

Risk assessment methodologies

Statistical analysis

cGMP regulations

Quality systems documentation

Technical writing

Leadership

Cross-functional collaboration

Lean/continuous improvement

Proficient with standard software

Travel up to 10%

Education

Advanced Degree + 4 years experience

Bachelor's Degree + 6 years experience

Preferred fields: Engineering, Science, Chemistry, Biology

Job description

Thermo Fisher Scientific in Allentown, PA is seeking a Validation Manager to lead validation activities ensuring product quality and regulatory compliance across equipment, utilities, facilities, and computer systems.

You will develop validation strategy, mentor a team, and coordinate cross-functional efforts to support cGMP standards and tech transfers in a fast-paced pharmaceutical environment.