- Lead multiple complex validation activities associated with computers, equipment, and processes.
- Develop and implement validation plans and associated documentation in the NDA drug approval process under the FDA Pre-Approval Inspection programs.
- Coordinate validation associated audit activities; establish rationales and technical defense positions.
- Negotiate with clients the validation requirements for projects. Resolve significant validation, product and regulatory issues. Plan and establish technical communications, document flow, testing requirements, and resources vital to complete the validation of a system.
- Support systems and new product introduction by serving as a technical resource, providing technical expertise, problem solving, and strategies for problem prevention.
- Participate as the validation representative in project team activities and process design to insure CGMP compliance and interdepartmental consistency within the validation program.
- Assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements as related to validation.
- Maintain current knowledge and serve as a technical resource for emerging trends and technologies.
- Coordinate and provide training and/or opportunities for career development of others.
- Coordinates the implementation of interdepartmental process validation programs.
- Performs validation functions to ensure accurate and timely completion with frequent decision making, coordination and communications required.
- Builds, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations.
- Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues.
- Minimum required education: Associate's degree in a scientific or production related discipline
- Higher level education preferred.
- 6 years' experience in the pharmaceutical industry required.
- 2 years validation experience required.
- Broad based knowledge of regulatory compliance requirements related to validation and relevant production controls.
- Strong interpersonal and communication skills.
- Ability to efficiently collaborate with others to achieve team goals and expectations.
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Process Validation Staff Engineer - Greenville, United States - Thermo Fisher Scientific
Description
Work Schedule
OtherEnvironmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/ Division Specific Information
The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectables.
How will you make an impact?
Provides validation expertise and supervision of multiple complex activities for process, equipment and/or computer validation associated with products produced by the Company. Supervises and/or leads lower-level staff as assigned. Serve as a principal technical expert in regard to validation activities associated with equipment, computers, and processes. Serve as the validation expert for the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/information/automation validation.
What will you do?
How will you get here?
Education:
Experience:
Knowledge, Skills, and Abilities:
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at *. Please include your contact information and specific details about your required accommodation to support you during the job application process.
*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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