Sr Quality Engineer

Allentown, PA
March 30 2017
Position Type
Full Time
Job Description

When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Fisher Clinical Services, part of Thermo Fisher Scientific, is a leading provider of global clinical supply chain. With unwavering commitment to service, science and process engineering, Fisher Clinical Services is powered by people with an exceptional commitment to quality, deeply instilled ethics of personal responsibility and unrivaled expertise. We are exclusively focused on serving the packaging and distribution requirements of clinical trials across the world. Whether planning, packaging, labeling, storing, or distributing the important supplies needed to perform clinical research, for more than 27 years Fisher Clinical Services has been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability and sustainability standards.

• Apply Good manufacturing Principles in all areas of responsibility.
• Demonstrate and promotes the company vision.
• Maintaining current equipment and facilities qualification documentation.
• Perform impact analysis of changes to facilities and equipment.
• Review and Approve equipment and facilities qualification documents to ensure compliance with all applicable internal and regulatory standards.
• Informs management of issues identified during qualification activities and recommends appropriate actions to address the issue(s).
• Drives continuous improvement to the site's equipment and facilities qualification/validation program.
• Assist in the authoring of site procedures related to equipment and facilities as required
• Monitor the site's calibration program.
• Monitor the site's preventative maintenance program.
• Author qualification documents as required.
• Conduct all activities in a safe and efficient manner.
• Other duties may be assigned to meet business/compliance needs.

Minimum Qualifications:
• Bachelors Degree.
• A minimum of 5 years in the pharmaceutical/related regulated industry.
• Experience with equipment and facilities validation Quality Systems.
• Must be detail oriented to detect errors or deficiencies with equipment and facilities qualification documentation.
• Possess the ability to use sound judgment in discerning if equipment and facilities qualification documentation accurately and completely reflects the documentation and requirements of the system.
• Utmost integrity and personal responsibility are required to maintain the highest ethical standards for regulatory compliance.

Preferred Qualifications:
• Good written and verbal communication skills.
• Thorough understanding of regulatory documentation requirements.
• Knowledge or prior experience with Current Good Manufacturing Practices (cGMP) for pharmaceutical products.
• Ability to work independently.
• Experience in Microsoft Word, Excel, and Power Point.

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.