Engineer Ii, Validation Jobs

Position: Validation Engineer II

Location: Greenville, NC

Company information

As part of the Thermo Fisher Scientific team, you will 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.

Business 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 and oral solid dose forms.

Position summary

Provides direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit, clients and corporate management through the leading and performing tasks associated with key quality functions. Supervises and/or leads lower level staff as assigned. 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. Crafts systems to drive compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company.

Key Responsibilities:

• Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions.
• Serves as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinates, reviews and prepares customer audit responses and reports.
• Manages, leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results.
• Coordinates regulatory inspections performed by the FDA, MCA and other regulatory agencies.
• Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification).
• Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
• Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales.
• Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.

Qualifications:

• Meaningful work experience in the pharmaceutical or a regulated industry, is preferred.
• High School or Diploma or GED is required.
• Effective time management and prioritization skills
• Bachelor’s degree in Engineering or Biological science related field is preferred. Four (4) years of applicable experience may be considered for equivalency to education.
• Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.
• Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented.

As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, tackle complex scientific challenges, drive technological innovation and support patients in need! #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.