Process Engineer/Technical Writer

Thermo Fisher Scientific - Allentown, PA

Full-time

Allentown, PA

1,001-5,000 employees

Computer and Electronic Product Manufacturing

About the position

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 dedication to service, science, and process engineering, we are powered by people with an exceptional dedication to quality, deeply instilled ethics of personal responsibility, and outstanding expertise. We are passionate about serving the packaging and distribution requirements of clients across the world. Whether planning, packaging, labeling, storing, or distributing important supplies, we have been committed to delivering the highest possible value while ensuring adherence to the highest level of quality, performance, reliability, and sustainability standards. CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time - a concept that we internally live by is "There is a Patient Waiting." Our outstanding blend of services includes project management, packaging, distribution, transportation management, specialty logistics, ancillary supply management, clinical supply optimization, bio-repository storage, and much more. Our more than 3000 employees in over 15 countries work hard every day knowing that what they do matters. Our company seeks a Technical Writer and Investigator, that investigates and responds to Quality Management System deviations and complaints to ensure root causes are identified and action plans are initiated to reduce the likelihood of recurrence. An ideal candidate has strong written and verbal communication to clearly and concisely enable Quality Assurance and clients to successfully analyze product impact.

Responsibilities

• Investigate and respond to Quality Management System deviations and complaints.
• Conduct in-depth interviews to acquire and detail accurate information.
• Complete CAPAs and effectiveness checks.
• Establish Quality recommendations for changes to Standard Operating Procedures and associated documentation.
• Compose technical concepts in a clear and concise manner to assist in the prevention of recurrence.
• Engage internal contacts at all levels company-wide (IT, Quality Assurance, Operations, Client Services, Supply Chain, etc.).
• Present information and respond to questions from Quality Assurance, senior management, peers, and clients.

Requirements

• High school diploma and one year of experience working in a Pharmaceutical Packaging/GMP environment.
• Strong written and verbal communication skills to convey technical concepts clearly and concisely.
• Experience in Microsoft Suite (i.e. Excel, Word, PowerPoint).
• Ability to read and interpret GMP and other regulatory requirements.
• Proficiency in skills required to read, understand, and follow SOPs and policies of a GMP environment.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Apply Root Cause Analysis techniques to identify the root cause and critical contributing factors to the event.
• Prioritization skills and strong dedication to timelines.

Nice-to-haves

• Experience in a fast-paced environment.
• Familiarity with Quality Assurance processes and standards.