QA Validation & Engineering Specialist

Catalent Pharma Solutions; Glen Burnie (MD); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Medical, dental and vision benefits

Paid time off & holidays

Career growth opportunities

Day-one benefits

Job summary

Catalent Pharma Solutions is hiring a Specialist, QA Validation & Engineering in Harmans, MD, to oversee quality for facilities, engineering and validation activities. This full-time onsite role supports continuous improvement across process validation, equipment qualification, and GMP utilities.

You will review validation documentation, support audits, and collaborate with cross-functional teams to ensure regulatory compliance and product quality.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related scientific discipline.
• Experience reviewing and approving process validation documents, including PPQ protocols and reports.
• Strong knowledge of FDA, EMA, ICH, and GMP requirements for process validation.

Responsibilities

• Act as QA rep for review/approval of process validation documents (VMPs, PPQ, reports).
• Provide QA oversight across the process validation lifecycle for regulatory compliance.
• Support cleaning validation protocols and reports.
• Collaborate with Manufacturing, Process Development, Validation, Engineering for program support.
• Review/approve deviations, investigations, CAPAs, risk assessments.
• Review/approve change controls impacting validated processes.
• Support audits with subject matter expertise on validation programs and quality systems.
• Review/approve calibration and preventive maintenance for validated systems.
• Perform additional duties as assigned by the manager.

Skills

Process validation

GMP knowledge

FDA/EMA knowledge

Deviation management

Change control

Risk assessment

IQ/OQ/PQ qualification

Quality systems

Collaborative teamwork

Education

Bachelor’s degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, or related discipline

Job description

Catalent Pharma Solutions is hiring a Specialist, QA Validation & Engineering in Harmans, MD, to oversee quality for facilities, engineering and validation activities. This full-time onsite role supports continuous improvement across process validation, equipment qualification, and GMP utilities.

You will review validation documentation, support audits, and collaborate with cross-functional teams to ensure regulatory compliance and product quality.