Validation Engineer

You will play a pivotal role in ensuring compliance acrossthe Process Development and Manufacturing. The Validation Engineer will assist the Benchtop product team with all aspects of the computer validation process across the Operations footprint.

Role Description:

Lets do this. Lets change the world. In this vital role you will be part of the Benchtop Product Team working on computerized systems validations (CSV) and GAMP (Good Automated Manufacturing Practice). This vital role ensures Amgen systems remain compliant with industry standards and comply with all regulatory requirements.

Roles & Responsibilities:

• Advising clients on how to meet compliance requirements using a risk-based approach.

• Develop validation documentation and standard operating procedures for various GxP applications.

• Develop test protocols that thoroughly test business requirements.

• Provide test execution oversight and assist with deviation recommendations as required, work with clients to develop validation plans to ensure that, at the end of the project, the system meets GxP requirements.

• Work with client business functions and subject matter experts to develop User Requirements Specification, Functional Requirements Specification, and/or Design Specifications as required

• Development of test validation scripts based on software design and configurations.

• Develop IQ/OQ scripts as required.

Basic Qualifications:

• Masters degree with 8 - 12 years of experience in validation/regulatory or related field OR

• Bachelors degree with 10 - 14 years of experience in validation/regulatory or related field OR

Functional Skills:

Must-Have Skills:

• Demonstrated experience with minimum of 3 to 5 years in pharmaceutical industry, focusing on Computer Systems Validations GAMP

• Experience with regulatory agencies FDA, EMEA, CFDA, and other regulatory agencies

• Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.

• Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.

• Expertise with ALM testing and ALM software

• Expertise in use Veeva (all modules CDocs, QMS, RIM, DocuSign, etc)

• Fluent knowledge of rules and regulations: GAMP 5, 21 CFR Part 11 Compliance and CFR Part 210, 211 Compliance.

Preferred Skills:

• Ability to work independently, excellent problem solving and professional written communications skills.

• Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project), Experience with Smartsheets, Salesforce, Tableau a plus

• FDA Audit experience a plus & working with regulatory agencies

• Experience with instrument qualifications (IQ/OQ), validation plans, regulated workflows.

Soft Skills:

• Excellent leadership and team management skills.

• Strong transformation and change management experience.

• Ability to work effectively with global, virtual teams.

• Excellent analytical and troubleshooting skills.

• Ability to manage multiple priorities successfully.

• Strong presentation and public speaking skills.

• Strong verbal and written communication skills.

• High degree of initiative and self-motivation.