Career CategoryScientific
Job DescriptionAssociate Scientist - PKMD - Lab OperationsWhat you will doLet's do this. Let's change the world. In this vital role you will be responsible for ensuring that laboratory equipment, computerized systems, and associated processes remain compliant, fit for intended use, and inspection-ready throughout their lifecycle. The role provides validation leadership and support for GxP-regulated systems and equipment, including planning, risk assessment, change control, testing, documentation, implementation, maintenance, and retirement activities.
This position partners with system owners, laboratory scientists, IT, automation, Quality, Data Integrity, and external vendors to maintain regulatory compliance and data integrity in alignment with 21 CFR Part 58 and Part 11 requirements. The Associate Scientist also supports equipment setup and assists scientific staff with compliant data generation, quality control, user access, reporting, and SOP adherence.
Key Responsibilities:
Computerized System Validation (CSV)- Lead and support validation activities for computerized systems, laboratory software, and GxP-regulated applications.
- Develop validation strategies using risk-based validation principles.
- Author, review, and maintain validation deliverables including:
- Validation Plans (VPR)
- Risk Assessments
- Requirements Specifications
- Qualification Protocols
- Traceability Matrices
- Validation Summary Reports (VSR)
- Coordinate and execute qualification and validation testing activities.
- Ensure systems maintain a validated state throughout their lifecycle.
Change Control & Lifecycle Management- Lead validation assessments for equipment and system changes.
- Evaluate software upgrades, patches, configuration changes, and system enhancements.
- Participate in system implementation, expansion, relocation, and decommissioning activities.
- Support periodic reviews and lifecycle documentation maintenance.
Compliance & Data Integrity- Ensure compliance with applicable regulations, including GxP requirements and electronic records controls.
- Support audit readiness and regulatory inspections.
- Review system security, user access controls, audit trail functionality, and data integrity controls.
- Investigate and document validation exceptions, deviations, and corrective actions.
Cross-Functional Collaboration- Partner with laboratory operations, system owners, SMEs, IT, automation, quality, and vendors.
- Facilitate validation kickoff meetings, testing coordination, and issue resolution.
- Provide validation guidance for new technologies, laboratory instruments, and business processes.
- Support business continuity and disaster recovery planning for regulated systems.
Documentation & Training- Maintain complete and accurate validation documentation in approved quality systems.
- Develop and update validation procedures, work instructions, and templates.
- Train users and stakeholders in validation processes and change control requirements.
- Contribute to continuous improvement initiatives that enhance efficiency while maintaining compliance.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Associate Scientist we seek is a researcher with these qualifications.
Basic Qualifications:Master's degree and 1 year of laboratory experience
OR
Bachelor's degree and 3 years of laboratory experience
Preferred Qualifications:- Advanced degree preferred.
- 5+ years of experience supporting equipment, quality, laboratory operations, information systems, or regulated environments.
- Experience with computerized system validation and lifecycle management.
- Experience working in GLP, GCP, or other regulated environments.
- Experience supporting laboratory instruments, data systems, or automation platforms preferred.
- Strong understanding of validation methodologies.
- Knowledge of risk-based validation approaches.
- Familiarity with validation documentation, traceability, testing, and change control.
- Understanding of data integrity principles and regulated system requirements.
- Excellent technical writing and documentation skills.
- Strong organizational, communication, and project coordination abilities.
- Ability to work effectively across multiple functions and priorities.
- Systems remain inspection ready and in a validated state.
- Validation deliverables are completed accurately and on schedule.
- Regulatory findings related to validation and data integrity are minimized.
- Effective support of system implementations, upgrades, and lifecycle activities.
- Strong stakeholder satisfaction and cross-functional collaboration.
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-winning time-off plans
- Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Salary Range91,528.00USD -123,832.00 USD
