Manufacturing Process Specialist

23 hours ago


The Municipal District of Carlow, Ireland PSC Biotech Corporation Full time
About PSC Biotech Corporation

PSC Biotech Corporation is a leading biotechnology 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 in more than 23 countries worldwide.

Our unique selling point lies in our ability to align employee value proposition with the needs of our clients, providing them with unparalleled career development opportunities. We offer permanent employment contracts that give exposure to working in top pharmaceutical client sites, fostering a diverse-cultural work setting.

We empower our employees through learning and development programs, mentorship, and constant guidance to facilitate career progression. Our goal is to create high-performing teams that exceed client expectations regarding quality, scalability, and business unit deliverables.

Job Description:

We are seeking a highly skilled Aseptic Manufacturing Engineer to provide technical support for manufacturing and new product introduction. The successful candidate will design, author, review, approve, and execute process simulations studies in support of new product introduction and ongoing manufacturing support.

The ideal candidate will have experience in aseptic sterile manufacturing environments, strong knowledge of sterile manufacturing processes, and the ability to coach and lead change. A bachelor's degree or higher in a science, engineering, or technical discipline is preferred.

The successful candidate will be responsible for:

  • Serving as technical support for manufacturing and new product introduction
  • Designing, authoring, reviewing, approving, and executing process simulations studies
  • Providing technical input into quality notifications by authoring, reviewing, and approving process simulation-related investigations
  • Designing, authoring, reviewing, approving, and executing commercial and process simulation qualification/validation documentation and studies
  • Performing data analysis and making informed decisions/recommendations
  • Supporting continuous improvement through Lean Six Sigma methodologies
  • Leading and participating in projects, system failure investigations, and investigation reports
  • Executing/developing change controls to support the Process Simulation process
  • Contributing to Kaizen events as appropriate
  • Performing root cause analysis of system failures and implementing subsequent corrective action
  • Serving as technical engineering representative for internal technical group discussions and representing technical operations at global technical forums
  • Participating in cross-functional or single-function teams, including liaising with vendors or above-site groups
  • Driving compliance with client Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP)

Core Competencies:

  • Technical knowledge of regulatory/code requirements, equipment, and process validation
  • Report, standards, policy writing skills required
  • Lean Six Sigma Methodology experience desired

Benefits:

We offer a competitive salary and benefits package, including excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and external customers in a team-oriented manner.

The successful candidate will be eligible to work full-time in Ireland, holding EU, UK, Stamp 1G, or Stamp 4 visa status. Visa sponsorship is not provided.



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