Validation Area Specialist I/II - SDF

Location: Durham, North Carolina, United States. On-site pharmaceutical manufacturing role with up to 10% travel.

Company

hirify.global is a global healthcare company developing and manufacturing treatments for diabetes, obesity, and other serious chronic diseases.

What you will do

• Plan, perform, review, and approve validation and revalidation activities for pharmaceutical manufacturing equipment and systems.
• Prepare and review validation protocols, procedures, specifications, and quality documents.
• Manage change requests related to revalidation and other assigned validation activities.
• Investigate failures, identify root causes, and support corrective actions and investigation closure.
• Coordinate with IT, Metrology, and other departments to complete validation deliverables on schedule and within budget targets.
• Support audits, inspections, safety requirements, environmental requirements, and continuous improvement activities.

Requirements

• Bachelor’s degree in engineering, pharmaceutical sciences, or a related field and at least two years of validation experience in the pharmaceutical or medical device industry.
• Equivalent pathways may include an associate degree with at least four years of relevant experience, or a high school diploma with at least six years of relevant experience.
• Experience with validation and quality documentation, cGMP practices, and regulatory compliance is preferred.
• Knowledge of equipment, sterilization, cleaning, utilities, or computer validation is preferred.
• Strong written and verbal communication skills, basic Microsoft Word and Excel skills, and experience working with cross-functional teams are preferred.
• Ability to work in an open office environment and travel up to 10% of the time.

Culture & Benefits

• Paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective from day one.
• Guaranteed 8% 401(k) contribution with an individual company match option.
• Paid parental and family medical leave, life and disability insurance, and tuition assistance.
• Access to hirify.global-marketed pharmaceutical products and employee referral awards.