QA Validation & Engineering Specialist - Onsite GMP

Catalent; Harmans (MD); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Defined career path

Annual performance reviews

Diverse, inclusive culture

Medical, dental & vision benefits

Tuition reimbursement

8 paid holidays

Job summary

Catalent’s Harmans, MD onsite facility is seeking a Specialist, QA Validation & Engineering to provide quality oversight of Facilities, Engineering and Validation, ensuring compliance with US regulations, industry standards and internal policies.

You will support process validation programs, cleaning validation, and change controls; collaborate across Manufacturing, Process Development, Validation and Technical Services to drive continuous improvement; and assist with audits and qualification

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related scientific discipline.
• 1–3 years of GMP-regulated pharmaceutical/bi biotechnology manufacturing experience.
• Experience reviewing process validation documents including PPQ protocols/reports.
• Strong knowledge of FDA, EMA, ICH, and GMP requirements for process validation.
• Experience with deviation management, investigations, CAPAs, risk assessments, and change control systems.

Responsibilities

• Act as QA representative for review and approval of process validation lifecycle documents (VMPs, PPQ protocols/reports, studies).
• Provide QA oversight throughout the process validation lifecycle to ensure regulatory compliance.
• Support cleaning validation programs through protocol and report review and approval.
• Collaborate with Manufacturing, Process Development, Validation, Engineering, and Technical Services to support validation programs and improvements.
• Review and approve deviations, investigations, CAPAs, and risk assessments related to process validation activities.
• Review and approve change controls impacting validated manufacturing processes and associated validation documentation.
• Support audits by providing SME on process validation programs and quality systems.
• QA review of qualification activities for equipment, processes, cleanrooms, facilities, and GMP utilities.
• Review and approve calibration and preventive maintenance documentation for validated systems/equipment.
• Perform additional duties as assigned by the manager.

Skills

GMP experience

Process validation

Deviation management

Change control

Regulatory compliance

Education

Bachelor's degree

Tools

Validation Master Plans

Job description

Catalent’s Harmans, MD onsite facility is seeking a Specialist, QA Validation & Engineering to provide quality oversight of Facilities, Engineering and Validation, ensuring compliance with US regulations, industry standards and internal policies.

You will support process validation programs, cleaning validation, and change controls; collaborate across Manufacturing, Process Development, Validation and Technical Services to drive continuous improvement; and assist with audits and qualification