Validation Area Specialist I/II - Equipment & Process

Initial Therapeutics, Inc.; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Job summary

Novo Nordisk in Durham, NC is seeking a Validation Engineer to plan, manage and perform validation projects for manufacturing systems and equipment. You will support deviation investigations, write change requests, and collaborate with IT, Metrology and other stakeholders to ensure quality and cost effectiveness within budget.

The role requires a degree in engineering or related field and 2+ years of validation experience, with strong communication and problem-solving skills.

Qualifications

• Bachelor’s degree in engineering, pharmaceutical sciences or related field from an accredited university; 2 years validation experience.
• Alternate: Associate’s degree with 4 years validation experience.
• Alternate: High School diploma with 6 years validation experience.
• Experience with cGMP documentation practices preferred.
• Experience in core validation areas (equipment, sterilization, cleaning, process utilities or computer validation) preferred.
• Strong oral & written communication skills preferred.
• Experience with validation test equipment including Ellab Validator preferred.
• Experience working with cross-functional teams preferred.

Responsibilities

• Perform, review & approve validation/revalidation.
• Coordinate with multiple departments to schedule validation activities.
• Review & approve documents per regulatory requirements.
• Prepare and approve validation protocols and change control documents.
• Investigate deviations and apply root-cause analysis to prevent recurrence.
• Ensure data integrity and acceptance criteria are met.
• Assist audits and inspections with validation concepts and approaches.
• Support continuous improvements in validation processes.

Skills

Communication skills

Team collaboration

Problem-solving skills

Attention to detail

Technical writing

Education

Bachelor’s degree in engineering/pharmaceutical sciences or related field

Associate’s degree in engineering/pharmaceutical sciences

High School Diploma or equivalent

Tools

Ellab Validator

Microsoft Word

Excel

Job description

Novo Nordisk in Durham, NC is seeking a Validation Engineer to plan, manage and perform validation projects for manufacturing systems and equipment. You will support deviation investigations, write change requests, and collaborate with IT, Metrology and other stakeholders to ensure quality and cost effectiveness within budget.

The role requires a degree in engineering or related field and 2+ years of validation experience, with strong communication and problem-solving skills.