Process Validation Scientist

About the role

Remedica, a Cyprus-headquartered EU-based generics CDMO, is looking for a Process Validation Scientist. The role supports the planning, coordination, execution and evaluation of process validation activities in line with GMP requirements, regulatory guidelines and company procedures, so that manufacturing processes stay validated throughout the product lifecycle. It works with cross-functional teams to generate, analyse and interpret validation data, prepare validation documentation and support ongoing process monitoring.

Key responsibilities

• Check the weekly production schedule and decide whether a process needs validation.
• Review files, batch manufacturing records and other documents to carry out validation studies and write reports.
• Carry out risk assessments and help respond to product or process deficiencies raised by stakeholders, clients or authorities.
• Run speed-evaluation tests during compression and physical property testing when instructed by the PV Supervisor.
• Update the process validation database through the ERP system.
• Monitor processes under validation during manufacturing and evaluate data and analytical results.
• Prepare, review and execute validation protocols and reports, and use statistical tools to assess process capability and consistency.
• Support investigations of process deviations and OOS results, contributing to root cause analysis and CAPAs.
• Ensure compliance with GMP and internal quality systems, and report evidence that products meet acceptance criteria.

Required profile

• Bachelor's degree in Biology, Chemistry, Natural Sciences, Biomedical Sciences or a related field; Master's degree is an advantage.
• 2-4 years of experience in pharmaceutical, biotechnology or other regulated manufacturing environments, preparing and executing validation protocols and reports.
• Fluent English, written and spoken; Greek is an advantage.
• Ability to collaborate with internal departments and solve problems proactively.

Required skills

• Excellent knowledge of Microsoft Office tools.
• Statistical and data analysis software such as Minitab or JMP.
• Familiarity with quality management systems, electronic document management systems and manufacturing software.

What we offer

• Competitive compensation including 14 salaries.
• Provident fund and additional benefits.