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Engineer II, Validation

Location Greenville, ノースカロライナ州, アメリカ合衆国 Job Id R-01301833 Job Type フルタイム Category オペレーション Remote すべてオンサイト
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance、 Adherence to all Good Manufacturing Practices (GMP) Safety Standards、 Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed、 Cold Room/Freezers -22degreesF/-6degrees C、 Fluctuating Temps hot/cold、 Laboratory Setting、 Loud Noises (Equipment/Machinery)、 No contact lens allowed; prescriptive glasses will be provided、 Office、 Rapid flashing lights、 Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)、 Standing for full shift、 Strong Odors (chemical, lubricants, biological products etc.)、 Various outside weather conditions、 Warehouse、 Will work with hazardous/toxic materials、 Working at heights

Job Description

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:

  • Manages, leads, schedules, and completes multiple projects of high complexity with multi-disciplinary departments to ensure accurate completion of results.
  • 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.
  • Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales.
  • Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions.
  • Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.
  • Coordinates regulatory inspections performed by the FDA, MCA and other regulatory agencies.
  • Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
  • Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification).
  • Qualifications:
  • 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.
  • Meaningful work experience in the pharmaceutical or a regulated industry, is preferred.
  • Capable of growing in a fast-paced environment, adept at managing multiple tasks under pressure.
  • Effective time management and prioritization skills
  • 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.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

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