Operations Project Engineer

Puurs, Flanders, be
Company: AUSY
Category: Computer and Mathematical Occupations
Published on 2021-07-26 14:08:42

Your job

In the position of Operations Project Engineer, your understanding of Quality Control instruments will help our client meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from R&D. 

As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.

As Operations Project Engineer you will: 

  • Contribute to the completion of complex projects , manage own time to meet agreed targets and develop plans for work activities on own projects within a team
  • Lead efforts to improve process performance, procedures and reporting to meet changing quality and regulatory compliance
  • Able to create , review , and approve compliant test method transfer and validation protocols and reports and equipment qualification/computer validation records
  • Perform tasks associated with maintaining Current Good Manufacturing Practices {part of GxP} compliant Quality Control and Stability laboratories
  • Support preparation of media, receipt, storage and handling of Bio ball cultures, and investigations related to microbiology
  • Perform testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and Environment Monitoring samples
  • Support detailing requirements for Laboratory Information Management System builds, building, testing and managing its Master Data changes
  • Review and authorize all laboratory data and have an extensive overall knowledge of all laboratory operations
  • Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects
  • Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report
  • Participate in out-of-specification and failure investigations and recommend corrective actions and demonstrate problem solving abilities
  • Train junior colleagues and may develop training plans and/or oversee training activities for groups
  • Your profile

  • You have, at least, a Bachelor's Degree with minimum 3 years of relevant experience in the pharmaceutical industry. A Master degree or PhD is nice to have
  • You have a good knowledge of  computer system hardware , infrastructure and networks
  • You have technical Skills Experience in MLT method validation and testing and experience in microbiological testing of water
  • You have a good understanding of pharmaceutical manufacturing , packaging , and quality assurance operations
  • You are detail oriented with knowledge of Quality systems, research unit clinical and analytical Laboratory environment
  • You have excellent effective written and verbal communication and interpersonal skills in English and Dutch
  • You are eligible to work in Belgium
  • Your benefits

    As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extras like:

  • Meal vouchers of €7
  • Net representation cost of €50
  • Hospitalization insurance
  • Car + unlimited fuel card OR home-work compensation
  • 32 holidays
  • End-of-year bonus
  • Pension plan
  • ECO vouchers
  • Opportunities to follow trainings
  • And on top of this you'll improve your skills and become an even bigger expert!

    Your employer

    As an Operations Project Engineer you will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help our client provide safe drugs to patients. 

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