Specialist, QA Validation & Engineering

Catalent•Harmans, MD

1d•Onsite

About The Position

We have an opportunity for a Specialist, QA Validation & Engineering to join our team. In this role, you will provide Quality oversight of Facilities, Engineering, and Validation groups to ensure compliance with US regulations, industry standards, and internal policies. You will support continuous improvement for processes, equipment, utilities, and computer systems. This position serves as a key Quality resource for Engineering, Facilities, and Validation organizations.

Requirements

Bachelor's degree in Engineering, Life Sciences, Pharmacy, Biotechnology, Chemistry, Microbiology, or a related scientific discipline.
Minimum 1-3 years of experience in a GMP-regulated pharmaceutical, biotechnology, or biologics manufacturing environment.
Experience reviewing and approving process validation documents, including Process Performance Qualification protocols and reports.
Strong knowledge of FDA, EMA, ICH, and current Good Manufacturing Practice requirements applicable to process validation.
Experience with deviation management, investigations, corrective and preventive actions, risk assessments, and change control systems.

Nice To Haves

Experience supporting equipment qualification (Installation Qualification, Operational Qualification, Performance Qualification).
Experience with facility and utility qualification.
Experience with cleaning validation and computerized systems validation.
Familiarity with biologics, cell therapy, gene therapy, plasmid manufacturing, or sterile manufacturing processes.

Responsibilities

Act as Quality Assurance representative for review and approval of process validation lifecycle documents, including Validation Master Plans, Process Performance Qualification protocols and reports, engineering and characterization studies, and Continued Process Verification documentation.
Provide QA oversight throughout the process validation lifecycle to ensure compliance with regulatory requirements, industry standards, and internal procedures.
Support cleaning validation programs through protocol and report review and approval.
Collaborate with Manufacturing, Process Development, Validation, Engineering, and Technical Services teams to support process validation programs and continuous improvement initiatives.
Review and approve deviations, investigations, corrective and preventive actions, and risk assessments related to process validation activities.
Review and approve change controls impacting validated manufacturing processes, ensuring proper assessments, implementation plans, and supporting validation documentation.
Support client, regulatory, and internal audits by providing subject matter expertise on process validation programs and quality systems.
Support QA review of qualification activities for manufacturing equipment, process equipment, cleanrooms, facilities, and GMP utilities.
Review and approve calibration and preventive maintenance documentation to ensure continued suitability of validated systems and equipment.
Perform additional duties as assigned by the manager.