About the Role
Randstad InHouse Services, specializing in Pharma, seeks a Product and Process Engineer.
This role involves coordinating, planning, and executing technical aspects of development/validation/transfer of manufacturing and packaging processes, as well as ensuring knowledge transfer to production departments. Additionally, you will contribute to identifying process and productivity improvement solutions.
Responsibilities
* Technical coordination, planning, and execution of development/validation activities for manufacturing/packaging processes related to new product transfers, process improvements/maintenance, and qualification of new raw materials (active ingredients/excipients) and packaging components.
* Coordination, preparation, and review of documentation required for development/validation trials (protocols/reports, operating instructions, sampling plans, control charts, Master Formula, production orders).
* Coordination, planning, and execution of development/validation activities for equipment cleaning procedures.
* Updating SOPs regulating department activities in line with company guidelines and regulations.
* Collaboration and support for technical aspects to other plant functions (QA, QC, Regulatory, Procurement, Engineering) for evaluation/preparation of documents such as Change Controls, Master Formulas, deviations, investigations, Risk Assessments, Technical Assessments, Periodic Product Reviews (PPRs), User Requirement Functional Specifications (URFS), HACCP manuals.
* Collections and evaluations of process data (in-process control) and QC analytical data for report preparation.
* Collaboration and support to Production for technological issues in commercial productions.
* Technical support to Operations and Opex for continuous improvements/simplification initiatives impacting performance, productivity, and loss reduction.
Requirements
* Scientific University Degree in Chemistry, Pharmacy, Pharmaceutical Technology and Chemistry, Chemical Engineering, Biology, Biotechnology.
* 2-5 years experience in a GxP pharmaceutical regulated environment.
* Experience with process validation of pharmaceutical and dietary supplement products of different forms (coated/uncoated tablets, capsules, granules, creams) and packaging technologies (blisters, sachets, sticks, bottles, tubes). Familiarity with microbiological sampling and experience in validation of probiotics products would be a plus.
* Experience with cleaning validation of GMP production areas.
* Knowledge of statistical software (e.g., Statistica, Minitab).
* Good knowledge of written and spoken English.
* Strong relationship management, including the ability to work with inter-functional teams and in a matrix organization with multiple stakeholders interface.