Technical Engineer Filling Amsterdam • Prothya Biosolutions

1.      Technical SME and Go-to Person

• Is the focal point of contact for operators when assistance for technical issues is needed.
• Supports day-to-day technical activities for production systems, including equipment monitoring, calibration follow-up, supporting start-up activities and troubleshooting.

2.      Process Validation and Root Cause Analysis

• Assists in executing process and equipment validation activities and collects data for validation documentation. Supports root cause analysis by providing technical observations and implementing defined corrective or preventive actions

3.      Continuous Improvements

• Participates in improvement initiatives to enhance equipment performance and process reliability.

4.      Technical Training

• Provides technical training on the shopfloor to production teams, ensuring all employees are skilled in operating, understanding, maintaining, and troubleshooting production equipment and systems.

5.      Support during Mainentenance Stops

• Supports the production team during maintenance stops providing support checking work permits, adherence of external parties to Prothya guidelines and guides the acceptance testing process after the maintenance stop.

6.      EHS

• Follows all applicable safety procedures and instructions, uses PPE correctly, and immediately reports unsafe conditions or environmental incidents.

GxP

Has understanding of existing regulatory GxP requirements (within area of own expertise). Interacts cross functionally to ensure GxP compliance and writes SOPs. Follows mandatory GxP training and maintains an appropriate training record. Writes GxP documentation such as deviations and change control records.

Your Profile: 

• Bachelor’s degree in a technical field such as Mechanical Engineering, Chemical Engineering, Biotechnology, or a related discipline.
• 3+ years of experience in a technical position within pharmaceutical, biotechnology or food industries
• Proven expertise in process validation, root cause analysis, and equipment management.
• Experience in  Supporting operational activities and improving operational performance
• Strong knowledge of production processes and validation protocols.
• Knowledge of equipment, installations and maintenance processes
• Expertise in conducting root cause analyses Proficient in project management and leading multidisciplinary teams.
• Ability to train and coach technical/operational teams.
• Excellent problem-solving skills and attention to detail.
• Strong communication and collaboration abilities.
• Proficiency with technical systems and software tools (e.g., Mastercontrol, SAP, etc.).
• Fluency in English, with strong written and verbal communication skills.

What we offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.