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Senior/Consultant (Manufacturing Science and Technology)



  • Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:
    • Process Equipment
    • CIP / SIP
    • Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations
    • Method validation (analytical chemistry, biochemistry, microbiological)
    • Enterprise system (LIMS, QMS)
  • Develop risk assessment, system impact assessments, protocols and reports that support the qualification and validation requirements in the industry.
  • Develop validation protocols using a science and risk -based approach that meets regulatory requirements and industry best practices.
  • Review, analyse, interpret, and summarize system and process performance data of executed activities for report and presentation to management.
  • Investigate deviations, write investigation reports and create summary reports.
  • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

Professional Skills and Experience:

  • At least Bachelor’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 or more years of experience in several functions in pharmaceutical industry: commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, technology transfer.
  • Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4 and other regulatory requirements preferred
  • Experience with investigations into manufacturing / laboratory deviations and determination of product impact potential, root cause and corrective/preventive actions.
  • Knowledge of Validation Lifecycle approach (URS, FAT/SAT, commissioning, I/O/PQ Protocols, etc), guidelines, international regulatory requirements and other industry best practices.
  • Preferred to have experiences in multiple CQV discipline (such as CIP, SIP, process, utility, equipment, automation, computer system, lab system), preferably with advanced technical knowledge in one or more discipline.
  • Preferred to have experience interacting with or creating material for management and regulatory agencies.
  • Ability to communicate quality and risk-related concept to technical and non-technical audiences
  • Good organizational skill and ability to work independently
  • Good written and oral communication skills, presentation, and data analytics with center of excellence
  • Demonstrated ability to work as both a team player and independently
  • Good organizational skills and ability to follow assignments through to completion and meet timelines with commitment to task and attention to detail
  • For candidates from QC background, prefer to have experience in one or more of the following areas:
    • Good Aseptic technique.
    • Qualification of Laboratory Information Management System (LIMS) and/or MODA-EM including an ability to troubleshoot the system.
    • Designing and conducting test methods validation (sterility test, disinfectant test, etc.)
  • Fresh graduate is welcome to apply for junior position. Preference will be given to those with internship experience in the pharmaceutical industry.


  • Consulting roles with international healthcare clients in strategically relevant projects.
  • Working in a professional consultancy environment together with a highly motivated team.
  • Opportunity to take on leadership responsibilities 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.

Department: 110A Telok Ayer Street, Singapore

Location: Singapore

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Østmarken 3A, 2860 Søborg

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.

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