GMP Validation Engineer – Biotech/Pharma

BioSpace; Thousand Oaks (CA); On-site; USD 103,000 - 118,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus eligibility

Job summary

Amgen seeks a mechanical/biomedical/engineering professional to support the development, qualification, and validation of GMP test methods for vials, prefilled syringes, and injection devices. You will implement projects per established procedures, identify risks, and provide technical support across product lifecycles.

Telecommuting may be available. The role requires a Master’s degree in engineering and at least 1 year of related experience, plus familiarity with SAP, Trackwise, Minitab,

Qualifications

• Masters degree in an engineering field and one year of experience in related occupation.
• Familiarity with industry standards (ASME Y14.5, ISO, CFRs) and GMP/GDP regulatory environments.
• Experience with quality systems and GMP validation practices in biopharmaceutical manufacturing.
• Experience with SAP, Trackwise, Minitab, Maximo, or Smartsheet and design/prototyping tools such as SolidWorks or GrabCAD.
• Knowledge of validation protocols and documentation practices including change control and CAPA.

Responsibilities

• Support develop, qualify, and validate GMP test methods for vials, prefilled syringes, and injection devices.
• Coordinate test method development, design characterization, verification, and delivery with contractors to meet product assembly requirements.
• Assist with cost estimation for new processes, gauges, and equipment development; support capital request documentation.
• Author test method execution documents and gather requirements for safe equipment operation; ensure risk mitigation and timeline alignment with partners.
• May telecommute and support project lifecycles with clear communication across teams.

Education

Masters degree in Mechanical Engineering, Biomedical Engineering, Electrical Engineering or related field

Tools

SAP

Trackwise

Minitab

Maximo

Smartsheet

SolidWorks

GrabCAD

Polyjet 3D Printing

Job description

Amgen seeks a mechanical/biomedical/engineering professional to support the development, qualification, and validation of GMP test methods for vials, prefilled syringes, and injection devices. You will implement projects per established procedures, identify risks, and provide technical support across product lifecycles.

Telecommuting may be available. The role requires a Master’s degree in engineering and at least 1 year of related experience, plus familiarity with SAP, Trackwise, Minitab,