Product and Process Engineer

Randstad InHouse Services, specialty Pharma, is looking for a Product and Process Engineer.

As a Product and Process Engineer, you will coordinate, plan, and execute technical aspects of development, validation, and transfer of manufacturing and packaging processes, including equipment cleaning procedures. You will also contribute to identifying process and productivity improvement solutions.

Responsibilities include:

• Technical coordination and planning of development, validation activities for manufacturing and packaging processes, including transfer of new products, process improvements, and qualification of raw materials and packaging components.
• Preparation and review of documentation for development and validation trials, such as protocols, reports, operative instructions, sampling plans, control charts, Master Formulas, and production orders.
• Execution of validation activities for equipment cleaning procedures.
• Updating SOPs to align with company guidelines and regulations.
• Supporting other plant functions (QA, QC, Regulatory, Procurement, Engineering) with documents like Change Controls, Deviations, Investigations, Risk Assessments, and Periodic Product Reviews.
• Collecting and analyzing process and QC data for reports.
• Providing technological support to Production for commercial operations.
• Supporting continuous improvement initiatives to enhance performance and reduce losses.

Qualifications:

• Scientific University Degree in Chemistry, Pharmacy, Pharmaceutical Technology, Chemical Engineering, Biology, or Biotechnology.
• 2-5 years experience in a GxP pharmaceutical environment.
• Experience with process validation of pharmaceutical and dietary supplement products, including various forms and packaging technologies.
• Familiarity with microbiological sampling and validation of probiotic products is a plus.
• Experience with cleaning validation of GMP areas.
• Knowledge of statistical software (e.g., Statistica, Minitab).
• Good command of written and spoken English.
• Strong relationship management skills and ability to work with cross-functional teams in a matrix organization.

Location: Aprilia (LT)

Contract: Initial fixed-term contract of 12 months.

This role offers the opportunity to lead key activities and advance your career in a dynamic environment.