Validation Engineer APS - Katalyst Healthcares & Life Sciences

Boston, MA 02108

Responsibilities:
Client Protocol Execution:

Independently execute Airflow Pattern Studies (Client) to ensure compliance with GMPand regulatory requirements.
Revise, update, and maintain Client protocols and associated documentation, as necessary.

Validation Documentation:

Draft, review, and revise validation protocols, test plans, and reports, ensuring alignment with regulatory standards.
Maintain meticulous records of validation activities for audits and inspections.

CQV for Ongoing Maintenance:

Support the qualification and validation of equipment and processes related to facility operations and routine maintenance.
Perform periodic reviews and requalification of systems as required by internal policies.

Compliance Assurance:

Ensure all validation activities meet current regulatory guidelines, including FDA, EMA, and other applicable standards.
Collaborate with Quality and Operations teams to address findings and implement corrective actions as needed.

Qualifications:

Bachelor's degree in engineering, Life Sciences, or a related field.
5-8 years of experience in validation within a GMP-regulated environment.
Proven experience with Client protocol execution and document management.
Familiarity with CQV activities, particularly for maintenance and requalification efforts.
Strong understanding of validation principles and regulatory compliance (e.g., FDA, ICH, EU GMP).
Excellent written and verbal communication skills, with attention to detail and accuracy.
Ability to work independently and manage multiple tasks within defined timelines.

Preferred:

Source : Katalyst Healthcares & Life Sciences