QC Validation Specialist I – Equipment & Protocols

BioSpace; Clayton (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Leading pay and annual performancebonu

14 paid holidays

Health Insurance

Dental Insurance

Vision Insurance

8% 401K with company match

Parental & family medical leave

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Novo Nordisk in Clayton, NC, is seeking a Laboratory Validation Engineer to plan, manage and perform validation activities for QC equipment and processes.

You will collaborate with IT, metrology and other stakeholders to ensure quality, cost control and timely deliverables, while ensuring compliance with GMPs and corporate requirements.

The role offers growth within FFEx, with a focus on aseptic production support and cross-site collaboration.

Qualifications

• Bachelor’s Degree in Life Sciences, Chemistry, Engineering or related field.
• Associate’s Degree with 4+ years instrument, lab validation, or engineering in pharma.
• Minimum 2 years instrument, lab validation, or engineering experience in pharma.
• Experience writing and executing validation protocols preferred.
• Experience in managing projects preferred.
• Experience with electronic validation systems (TIMS) and SAP PM/QM a plus.
• Working knowledge of GMPs required.
• Ability to act as project manager driving equipment projects.

Responsibilities

• Accuracy and compliance of validation and equipment records.
• Validation responsible for QC equipment and instrumentation.
• Identify and handle deviations per proper procedures.
• Maintain stakeholder engagement and positive cooperation.
• Perform and oversee change control activities for QC equipment and systems.
• Follow all safety and environmental requirements in the performance of duties.
• Other accountabilities, as assigned.

Skills

Instrument validation

Project management

Technical writing

Validation protocols

Team collaboration

Education

Bachelor’s Degree in Life Sciences, Chemistry, Engineering or a relevant field

Associate’s Degree with 4+ years pharma experience

Tools

TIMS

SAP PM

SAP QM

Job description

Novo Nordisk in Clayton, NC, is seeking a Laboratory Validation Engineer to plan, manage and perform validation activities for QC equipment and processes.

You will collaborate with IT, metrology and other stakeholders to ensure quality, cost control and timely deliverables, while ensuring compliance with GMPs and corporate requirements.

The role offers growth within FFEx, with a focus on aseptic production support and cross-site collaboration.