Senior Analytical Method Validation Engineer (Onsite)

Abbott; Alameda (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Life Insurance

Short Term Disability

Long Term Disability

Critical Illness, Hospital coverage

401(k)

Job summary

Abbott is seeking a Quality Engineer III for a 12-month onsite assignment in Alameda, CA. You will independently review and approve analytical method validation/transfer, assess statistical data, and collaborate with QC, Manufacturing, R&D, and Regulatory Affairs to ensure regulatory compliance and product quality.

The role emphasizes risk-based decision making, data integrity, and applying GMP/ICH guidance to analytical methods across medical devices and diagnostics.

Qualifications

• Bachelor's degree in a scientific discipline with 7+ years in regulated quality roles.
• Experience reviewing analytical method validation, verification and transfer documentation.
• Strong knowledge of FDA/ISO/GMP/ICH requirements for analytical methods and lab controls.
• Experience with method validation per ICH Q2(R2), USP, and FDA guidance preferred.

Responsibilities

• Review/approve analytical method validation, verification, qualification and transfer protocols and reports.
• Provide technical assessment of validation studies for methods used in medical devices, pharma, and diagnostics.
• Evaluate validation parameters and statistical analyses; ensure scientifically sound conclusions.
• Lead investigations of deviations, OOS/OOT, CAPA and nonconformances with cross-functional teams.
• Support method transfer between labs, contract testing organizations, and manufacturing sites.
• Ensure compliance with regulations including FDA QSR, 21 CFR Parts 210, 211, 820 and ISO 13485.

Skills

Strong written and verbalCommunication

Statistical analysis

Risk-based decision making

Independent problem solving

Quality systems proficiency

Education

Bachelor's degree in Chemistry/Biochemistry/Biomedical Engineering or related

Advanced degree preferred (MS or PhD)

Tools

HPLC

Dissolution testing

Wet chemistry

Microbiological methods

Statistical software

Job description

Abbott is seeking a Quality Engineer III for a 12-month onsite assignment in Alameda, CA. You will independently review and approve analytical method validation/transfer, assess statistical data, and collaborate with QC, Manufacturing, R&D, and Regulatory Affairs to ensure regulatory compliance and product quality.

The role emphasizes risk-based decision making, data integrity, and applying GMP/ICH guidance to analytical methods across medical devices and diagnostics.