Senior Validation Engineer-Hybrid

2 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Full time
Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients across more than 23 countries worldwide. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing, and metrology services.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, providing opportunities to work with talented professionals in the Pharma/Biotech industry. We offer permanent employment contracts, exposure to top pharmaceutical client sites, and a diverse, multicultural work environment.

Employee Value Proposition

We prioritize our employees by offering career development, training, mentorship, and guidance to facilitate progression. Our goal is to create high-performing teams that exceed client expectations in quality, budget, and timelines.

Overview:

We are excited to offer a Senior Engineering Specialist (Validation) position, supporting Cleaning Validation activities, including Recovery/Cleanability studies, in a cGMP regulatory environment.

Requirements

Responsibilities:

  • Design, author, review, approve, and execute qualification and validation documentation and cycle development studies.
  • Develop and review change controls.
  • Resolve technical issues during study execution.
  • Engage with production, maintenance, and quality teams during validation activities.
  • Contribute to quality investigations and perform root cause analysis.
  • Support continuous improvement initiatives using Lean Six Sigma methodologies.
  • Represent validation in cross-functional projects and global forums.
  • Ensure compliance with global policies, procedures, regulatory requirements, and cGMP standards.
  • Maintain documentation, participate in audits, and support regulatory submissions.
  • Promote a safe and compliant work culture.
  • Perform other duties as assigned.

Experience, Knowledge & Skills:

  • Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers, recipe development, verification, and recovery studies.
  • Proven track record in a GMP manufacturing environment.
  • Technical qualifications in pharmaceutical, biological, chemical sciences, or engineering.
  • Experience with deviation management, change control, and leading technical projects.
  • Knowledge of process monitoring systems, automation (DeltaV), and data systems (Pi System) is beneficial.
  • Continuous professional development is desirable.
  • Understanding of regulatory standards (Irish, European, international).
  • Ability to analyze complex data and link findings to equipment performance.
  • Knowledge of equipment and process validation, sterile fill-finish processes, and equipment qualification.
  • Proficiency in Microsoft Office and related applications.
  • Excellent communication and interpersonal skills.

Additional advantageous knowledge areas include:

  • Filter validation, shipping qualification, equipment validation lifecycle, project management, isolator VHP/HVAC qualification, temperature control units, and vial/syringe technologies.

Qualifications & Education:

  • Relevant technical qualification in pharmaceutical, biological, chemical sciences, or engineering.
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