Specialist Validation Engineer Jobs

Create and maintain Benefit’s packaging material restriction list; alert packaging engineers if a package under development does not meet restrictions

1- 3 years of Experience in Packaging Development

Knowledge of cosmetic packaging materials & development

Knowledge of package safety tests

Maintain packaging material database and perform country specific import quantity calculations as needed for global reporting.

Complete country specific packaging material reporting to authorities as required to ensure company compliance to applicable packaging regulatory/environmental legislations globally.

Minimum of (5 – 8) five to eight years working experience in risk management in the Energy industry

Inventory of Models used within the Risk Management Function (RMF) and without as requested

Candidate must have general knowledge of energy markets, natural gas, power, oil crude & products, LNG and Freight

Excellent critical thinking and problem-solving skills

Strong analytical skills with attention to detailed data analysis and complex model configuration

Ability to multi-task and accommodate organic changes in requirements for deliverables

· Knowledge in working with current issue and effect management software

· Knowledge of risk/hazard analysis of business requirements leveraging GAMP 5

· Develops manual test cases with associated test runs using requirement and functional specification documents

· Knowledge of performing validation of BECS Software and Standard Operating Procedures

· Knowledge of FDA and international medical device regulations

· Prefer knowledge and understanding of applicable Regulated Software Application (RSA) modules

Demonstrates strong client service skills, teamwork, and collaboration.

Strong computer, scientific, and organizational skills

A combination of college and related technical experience will be considered (e.g., 14+ years’ experience)

Three years of regulatory experience including quality system/program development

Validation Specialist responsibilities include, but are not limited to, the following

Benefits & Perks To Foster Work/Life Balance

Strong understanding and experience with Aseptic techniques, cell manufacture processes and technologies preferred

Review of Validation protocol related data evidence

Review of CSV related data evidence

Review of QC related data evidence

Review of Tech Transfer related data evidence

Compile, analyze qualification/validation data, and develop Trace Matrices (TM).

Manage multiple projects, ensuring effective customer communication.

Demonstrate excellent written, verbal, and presentation skills.

Assess project scope, manage change, and solve problems.

Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of experience working within an FDA-regulated environment.

Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).

Experience in project management, test design, process flow, and troubleshooting.

5+ years relevant experience in validation and GMP.

Proficiency in manage multiple projects, setting priorities, and working in a fast-paced environment.

Experience using precision measuring instrument and electronic testing devices.

Excellent oral and written communication skills

Excellent organizational and interpersonal skills

Proficient technical writing and presentations skills so as to collaborate with technical and senior management staff

Extensive experience in reviewing/approving validation protocols and reports in support of facility/information systems commissioning, qualification, and change administration

Provide technical support and domain expertise for commissioning, qualification, and validation maintenance activities in AOH

Coordinate actions with Manufacturing, Engineering, Quality, and Supply Chain business to ensure that the overall Amgen validation requirements are met

Expertise in information systems qualification for manufacturing facility

Experience with SAFe and traditional Agile methodology coupled with strong GxP experience