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PE Consultant

NNIT A/S



Responsibilities:

  • Complete project tasks during different phases of the project including: Process Design, Conceptual Design, Basic Design, Detailed Design, Engineering Design, Construction, and Commissioning and Qualification.
  • Lead a Process team to establish process design basis, develop process options and optimizations of selected design, and review data for process flow sheets, Review P&IDs and process equipment specifications for Upstream, Downstream, Buffer, CIP, SIP and Utility systems.
  • Author, execute and/or review quality and test documents including User Requirement Specifications, Functional Design Specifications, Factory Acceptance Test, Site Acceptance Test, Commissioning, Qualification and other applicable project documents.
  • Participate in resolving process engineering investigations (Deviations, Troubleshooting’s, Discrepancies) with Quality Assurance/ Manufacturing/ Technology Transfer Teams.
  • Exercise good judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Professional Skills and Experience:

  • Bachelor’s/Master’s degree in technical discipline such as Engineering or Science or with experience relevant to the Job Description. Graduates of related discipline may also apply.
  • 3 years or more years of experience in Process/Project Engineering, validation, quality systems, quality operations, manufacturing, technology transfer or any combination thereof in Biopharmaceutical/Pharmaceutical industry (including Bulk Drug, Fill/Finish, Single Use, Monoclonal Antibody, and Gene Therapy facilities).
  • Knowledge of Project Quality, HAZOP studies, Mass Balance and Energy optimizations.
  • Preferred to have experience in Process Automation execution (Delta V, PCS).
  • Good understanding of ASME-BPE, FDA, EMA, ICH Q7, ICH Q8, ICH Q9 and other regulatory requirements.
  • Experience with investigations into manufacturing deviations, change controls and determination of product impact potential, root cause and corrective/preventive actions.
  • Professional Certification (ISPE, ASQ, PE, etc.) a plus

Offering:

  • Consulting roles for international healthcare clients in strategically relevant projects.
  • Work in a professional consultancy environment within a highly motivated team.
  • Opportunity to take on responsibility and to help shape our organization.
  • Excellent career development and growth opportunities in a growing premier consulting organization.
  • Structured training program and peer mentoring system to support competence and personal growth.

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NNIT A/S - hurtigt overblik


NNIT A/S
NNIT A/S
IT advisory, development and operations with a strong focus on life sciences, finance, the public sector and large enterprises with equally high demands on quality and security.

Placering
Østmarken 3A
2860 Søborg
Logo: NNIT A/S
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