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Senior Process Engineer - Sterile

Reference ID : 712MQ
Category :
  • Pharma / Biotech
  • General Manufacturing
Date Posted : Dec 7, 2017
Job Location
:
  • Leinster/Connaught
- Westmeath
Experience : 8+ years
Salary : Negotiable - DOE
Employment Type
:
Contract
Consultant
:
Michael McQuade
Contact Number : 086-0435195
The primary responsibilities are to provide technical support and expertise in the build-out, equipment procurement, commissioning, validation, and tech-transfer activities associated with the start-up of a new manufacturing facility.

Principal Responsibilities

Senior Process Engineer

Headcount Engineering is seeking a Senior Process Engineer for our client’s pharmaceutical facility in Athlone. The primary responsibilities are to provide technical support and expertise in the build-out, equipment procurement, commissioning, validation, and tech-transfer activities associated with the start-up of a new manufacturing facility. This is a contract position 12 months minimum.

The Senior Process Engineer will possess strong technical knowledge of aseptic manufacturing techniques, procedures and theory.

    • Knowledge of best practices in pharmaceutical product development, scale-up and technology transfer.
    • Specific knowledge of sterile pharmaceutical manufacturing processes and technologies.
    • Strong analytical skills, documentation skills and research skills.
    • Very strong problem-solving skills, ideally using formal tools e.g. FMEA.
    • Strong understanding of pharmaceutical industry regulatory requirements.
    • Clear understanding of the needs of cGMP and validation (DQ-PQ).
    • DoE knowledge desirable.
    • Knowledge of sterilization principles and practices
    • Strong communication and interpersonal skills. Highly motivated with ability to work effectively with multidisciplinary teams or independently

Qualifications & Requirements

  • Bachelor’s Degree in Mechanical Engineering, Pharmaceutical Sciences, or related Science discipline.
  • Minimum 8 years relevant experience in a pharmaceutical manufacturing environment, with at least 5 years’ experience in a comparable process engineering/technical services role.
  • Must have experience working in a sterile manufacturing environment. Ophthalmic manufacturing experience a plus.
  • Experience with many of the following processes:
    • Product introduction and transfer.
    • Cycle time and yield improvement initiatives.
    • Continuous improvement projects.
    • Equipment engineering runs, cycle development, PQ, Engineering Runs, Media Fills and PV.
    • Regulatory audit preparation and follow-up.
    • Equipment and component specification.
    • Component preparation – autoclaves, etc.
    • Vial or bottle filling of sterile solutions.
    • Cleaning (CIP/SIP) and sterilisation technologies.
    • Isolator technology incl. VHP.
    • Compounding – dispensing, formulation, sterile filtration, etc.
    • Primary container closure components.

For further information, please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie



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