Quality Control Validation Area Specialist I (Pharmaceutical Validation)

Location: Lexington, Massachusetts, United States; the posting also lists Clayton, North Carolina, United States. The role involves working in a production facility with equipment-handling and on-site physical requirements.

Company

hirify.global develops pharmaceutical products and production capabilities designed to improve long-term health outcomes for millions of patients.

What you will do

• Plan, manage, and perform laboratory validation activities for QC equipment and instrumentation.
• Review validation procedures and completed protocols for accuracy, completeness, and maintenance of the validated state.
• Lead change control activities for QC equipment and systems.
• Identify and manage deviations according to established procedures.
• Coordinate with IT, metrology, and other stakeholders to deliver quality, cost, and schedule objectives.
• Follow safety and environmental requirements, including procedures for working around hazardous materials.

Requirements

• Bachelor’s degree in life sciences, chemistry, engineering, or a relevant field.
• At least two years of instrument, laboratory validation, or engineering experience in the pharmaceutical industry or a related field.
• Working knowledge of GMP requirements.
• Ability to act as a project manager for equipment projects.
• Associate degree candidates may be considered with at least four years of relevant experience.
• Ability to move equipment or supplies weighing up to 33 pounds and perform close precision work; occasional ladder climbing and work at elevated heights may be required.

Nice to have

• Experience writing and executing validation protocols.
• Project management experience.
• Experience with electronic validation systems such as TIMS and SAP PM/QM modules.
• Experience writing and presenting technical or scientific documents and reports.
• Understanding of QC equipment and systems, end-user functionality, and lifecycle management.

Culture & Benefits

• Annual performance bonus and competitive pay.
• 14 paid holidays and generous paid time off.
• Health, dental, and vision insurance effective from day one.
• Guaranteed 8% 401(k) contribution with an additional company match option.
• Paid parental and family medical leave, tuition assistance, life and disability insurance, and employee referral awards.
• Mentorship and career development opportunities within a global organization working across multiple sites and cultures.