Engineer Specialist - Utilities Amsterdam • Prothya Biosolutions

Accountabilities:

SME

• Apply in-depth technical knowledge within your field of specialization
• Manage and improve relevant processes, methods, and systems
• Act as the first point of contact during audits, inspections, and issue escalations
• Lead problem-solving efforts related to deviations and process improvements within your technical domain
• Train and coach team members or operators on technical procedures.

Process owner

• Own and manage technical processes, systems, and methods within your specialization.
• Lead and coordinate improvement initiatives, validations, and system updates.
• Ensure processes remain compliant and aligned with internal and external developments.

Policies

• Translate regulatory and technical developments into improvements in procedures, plans, and processes.
• Contribute to the continuous development of policies within your field.
• Maintain partnerships with internal and external stakeholders.

Projects

• Lead and manage technical projects within your field of expertise, including the preparation of project plans, resource coordination, and reporting. Projects are typically department- or system-specific and executed in collaboration with cross-functional teams.

Quality

• Actively contribute to quality and validation improvements within your specialization.
• Perform root cause analyses, define corrective actions, and maintain technical and compliance documentation such as SOPs and validation reports.

Stakeholder Management

• Engage and align stakeholders such as production, QA, and engineering teams through subject matter expertise.
• Influence decisions on improvements, compliance, and technical solutions within your scope.

EHS

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

Your profile:

• Bachelor degree 
• At least 3 years of relevant experience in a GMP or technical environment.
• Knowledge of project management and experience with software such as Office, Trackwise and DoCompliance.
• Experience in process and research techniques.
• Strong analytical and problem-solving skills, including root cause analysis
• Able to coach and guide junior team members
• Stakeholder engagement and influencing skills
• Attention to detail and strong compliance mindset
• Excellent communication skills in both Dutch and English

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.