Validation Engineer #37195
Pharmaceutical

Austintown, OH Direct Hire Oct 17, 2024

Contemporary Staffing Solutions (CSS) is seeking a Validation Engineer to join our client in Austintown, OH! The Validation Engineer is responsible for overseeing and executing validation activities to ensure that systems, equipment, and processes comply with FDA and cGMP standards. This includes developing validation plans, performing testing (IQ, OQ, PQ, CSV, PV), analyzing data, and preparing reports. This role involves collaborating with cross-functional teams and overseeing external contractors. This permanent opportunity offers up to $100,000/year based on experience!

Key Responsibilities:

Develop and implement validation plans for equipment, processes, and utilities.
Ensure compliance with FDA, cGMP, and other regulatory standards.
Execute validation protocols (IQ, OQ, PQ, CSV, PV), analyze data, and prepare reports.
Plan and conduct cleaning verification and validation studies.
Requalify equipment and facilities as necessary.
Investigate deviations affecting quality, safety, and compliance.
Collaborate on validation strategies for site transfer projects.
Oversee equipment installation, commissioning, and validation.
Supervise external contractors and manage multiple projects.
Author, review, and approve validation documents and SOPs.
Support regulatory submissions and inspections.

Qualifications:

Bachelor’s degree in Engineering, Life Sciences, or related field.
5+ years of validation experience in a pharmaceutical or biotech environment.
Strong knowledge of cGMP requirements and validation principles.
Experience with CSV, commissioning, and qualification of pharma utilities and equipment.
Familiarity with industry standards (GAMP5, ASTM E2500).
Excellent technical writing and data analysis skills.

Contemporary Staffing Solutions (CSS) has been a leading provider of contract, temporary, temporary-hire & direct hire solutions. We began as a staffing agency and evolved to a national provider of workforce management solutions with a niche recruitment focus in Accounting & Finance, Call Center & Office, Human Resources, Sales & Marketing, & Information Technology. To learn more about CSS, visit our website: www.ContemporaryStaffing.com.