Process Engineer (Validation & Compliance) - Production

Kifisiá, GR (Onsite)  •  2 hours ago
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Job Description

UNI-PHARMA, is a leading Pharmaceutical Company with 62 years of experience in the production and distribution of pharmaceutical products. It holds the first place in sales (pieces) among the purely Greek companies of the Greek pharmaceutical market. It continues to grow its portfolio and the markets where it operates daily.

We invest in modern production facilities, advanced technologies & highly qualified people sharing the same values as we. UNI-PHARMA has been declared Top Employer in Greece for 2023, 2024, 2025 & 2026 by the Top Employer Institute. Our Compass is #TELEIA

  • Teamwork
  • Ethos
  • Learning
  • Excellence
  • Innovation
  • Accountability

We are currently seeking a highly motivated Process Engineer to join our dynamic Production team. The successful candidate will play a key role in optimizing manufacturing processes, improving operational efficiency, ensuring product quality, and supporting the continuous improvement of production activities across our pharmaceutical manufacturing operations.

As a key member of the team, you will collaborate closely with Production, Engineering, Quality Assurance, Quality Control, Supply Chain, and Maintenance departments to ensure efficient, compliant, and reliable manufacturing processes while supporting UNI-PHARMA’s commitment to operational excellence and innovation.

Key Responsibilities:

  • Monitor and optimize manufacturing processes to ensure consistent product quality, process robustness, and compliance with validated parameters and quality standards, while improving efficiency and productivity.
  • Analyze production data and identify opportunities for process improvement, waste reduction, and cost optimization.
  • Support new product introductions and technology transfer activities, and implementation of Product Dossiers into commercial manufacturing operations.
  • Organize and support cleaning activities to ensure compliance with approved cleaning procedures and validation requirements.
  • Coordinate and support Process Validation, Cleaning Validationm, Equipment Qualification and Continous Process Verification (CPV).
  • Ensure manufacturing and packaging operations are performed in compliance with approved Product Dossiers, GMP requirements, regulatory standards, and internal procedures.
  • Develop and maintain process documentation, work instructions, standard operating procedures (SOPs), and technical reports.
  • Prepare, review, implement, and maintain Production Batch Records, Packaging Protocols, Process Validation Protocols, Cleaning Validation Protocols, and associated reports.
  • Review manufacturing and packaging documentation to ensure alignment with approved Product Dossiers, validated processes, and regulatory commitments.
  • Investigate manufacturing deviations, non-conformities, and process-related issues, identifying root causes and supporting CAPA implementation.
  • Participate in Change Control, Risk Assessment, and continuous improvement initiatives related to manufacturing processes.
  • Support the continuous improvement of production processes through Lean Manufacturing and operational excellence initiatives.
  • Collaborate with Production and Maintenance teams to improve equipment performance, reliability, and overall manufacturing effectiveness.
  • Participate in cross-functional projects aimed at improving manufacturing capabilities and operational efficiency.
  • Contribute to troubleshooting activities and provide technical support to production operations.
  • Collaborate with Production, Quality Assurance, Quality Control, Engineering, Maintenance, and Regulatory Affairs to ensure ongoing process compliance and operational excellence.
  • Support regulatory inspections, customer audits, and internal audits related to manufacturing processes and validation activities.

Essential Qualifications:

  • Degree in Chemical Engineering, Pharmacy, Pharmaceutical Sciences, Industrial Pharmacy, Biotechnology, Mechanical Engineering, or a related scientific discipline.
  • Master's degree in Chemical Engineering, Pharmaceutical Technology, Industrial Pharmacy or a related scientific field is preferred.
  • Previous experience in pharmaceutical manufacturing, process engineering, validation, or production support.
  • Strong knowledge of Good Manufacturing Practices (GMP) requirements and pharmaceutical manufacturing operations.
  • Strong knowledge and hands-on experience in Process Validation and Cleaning Validation activities.
  • Experience in preparing, reviewing, and maintaining validation protocols, reports, production documentation, and technical procedures.
  • Strong understanding of Product Dossiers and their implementation within manufacturing and packaging operations.
  • Experience with Deviations, CAPAs, Change Control, and Quality Risk Management processes.
  • Excellent analytical, problem-solving, and organizational skills.
  • Strong communication and cross-functional collaboration skills.
  • Proficiency in MS Office applications, particularly Excel, Word, and PowerPoint.
  • Excellent organizational and time management abilities.
  • Ability to work effectively in a fast-paced manufacturing environment.
  • Excellent command of the Greek & English language (both oral & written).
  • Results-driven mindset with a strong focus on quality, efficiency, and continuous improvement.

Preferred Qualifications:

  • Experience in oral solid dosage forms, liquids, semi-solids, or sterile pharmaceutical manufacturing.
  • Experience with Product Dossier compilation, transfer, implementation, and lifecycle management.
  • Knowledge of Annex 15 Qualification and Validation principles.
  • Experience supporting regulatory inspections and customer audits.
  • Knowledge of Lean Manufacturing, Six Sigma, or Operational Excellence methodologies.
  • Experience working within a highly regulated pharmaceutical manufacturing environment.

Our vision is to improve people’s lives...

That is why we are committed to serve medical science with passion, creativity and ethos, having human life as our top priority.

UNI-PHARMA is an equal opportunity employer. We celebrate diversity and we are committed to provide a workplace that fosters creativity, growth, and inclusion.

This position offers an exciting opportunity to be part of a fast-paced and innovative manufacturing environment where your contributions will directly impact operational excellence, process efficiency, product quality, and business performance. If you are passionate about process optimization, manufacturing excellence, and continuous improvement, we would love to hear from you.

Apply today to become a part of our transformative journey in the pharmaceutical industry!

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