Manager Industrial Automation

Prothya Biosolutions makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. As Manager Industrial Automation you are responsible for managing an automation team to maintain, troubleshoot, and optimize computerized systems to ensure safe, available, efficient, and compliant production processes.

Lead and develop the automation team

Overview

Provide direction, coaching, and performance management for a team of automation professionals, fostering a culture of ownership, technical excellence, and continuous improvement.

The automation team consists of 5 technicians (who rotate 1 week per 5 weeks on standby duty to support production outside working hours), 1 CSV specialist and 1 automation engineer.

Responsibilities

• Set team priorities, allocate resources, and manage workload across maintenance, troubleshooting, and project activities.
• Develop competencies within the team through training and mentoring.
• Define clear roles, responsibilities, and performance objectives.
• Promote cross-functional collaboration with Engineering, IT, Validation, and Manufacturing.

Ensure Reliable Operation and Maintenance of Automation Systems

Overview: Oversee the preventive and corrective maintenance, troubleshooting, and lifecycle management of all site automation systems, ensuring reliability and data integrity in a GMP environment.

Responsibilities

• Ensure timely response and resolution of automation-related breakdowns and deviations.
• Maintain system documentation (architecture, configuration, change records) in compliance with GMP.
• Plan and oversee execution of preventive maintenance and periodic reviews.
• Coordinate with IT on infrastructure reliability, cybersecurity, and virtualization platforms supporting automation systems.

Drive Continuous Improvement and Project Execution

Overview: Lead or support automation projects, system upgrades, and digitalization initiatives that improve performance, compliance, and efficiency of manufacturing operations. Develop medium- and long-term automation strategy with ownership, obtain cross-functional buy-in, and drive actionable projects to completion with ongoing communication and escalation where needed.

Responsibilities

• Identify and implement improvements to automation systems, user interfaces, and data collection.
• Support or lead automation scope in capital projects (URS, design review, FAT/SAT, IOPQ).
• Collaborate with Engineering and Manufacturing on new equipment integration.
• Standardize automation platforms and documentation practices across the site.

Maintain Compliance and own Computerized System Validation (CSV)

Overview: Ensure all automation systems are validated and maintained in accordance with internal policies and regulatory expectations (GAMP 5, 21 CFR Part 11, EU GMP Annex 11).

Responsibilities

• Oversee CSV activities for new and existing systems.
• Ensure changes are managed under the site change control process.
• Partner with QA and Validation to maintain inspection readiness.
• Support internal and external audits regarding automation and CSV.

GxP

• Has a broad and in-depth understanding of existing and emerging regulatory GxP requirements within own field of expertise.
• Takes GxP requirements very seriously during preparation, execution and reporting of GxP activities.

Your Profile

• Master's degree in Automation Engineering, or a related field.
• At least ten years of experience in a pharma/GMP regulated environment. Strong background in either PLC, SCADA, DCS or MES; management experience highly preferred.

Leadership & Management Skills

• Strong people leadership and coaching skills; ability to develop technical talent.
• Able to foster a culture of ownership, high quality work and continuous improvement.
• Structured and decisive, with good prioritization in a dynamic environment.
• Cross-functional communication and stakeholder management.
• Ability to balance technical depth with GMP and business priorities.

Technical Knowledge

• Strong understanding of GMP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience with automation systems such as PLCs, SCADA, DCS, HMIs, MES and historian systems.
• Familiarity with industrial communication protocols (e.g., Profibus, ControlNet, Modbus, Ethernet/IP).
• Understanding of IT/OT integration, virtualization, and cybersecurity in GMP systems.
• Experience with Computerized System Validation (CSV) lifecycle and documentation.
• Preferred: Experience with systems used in pharmaceutical manufacturing (e.g., Siemens, Rockwell, Aveva Citect, PI, system platform, historian).
• System build experience on-site or with a system integrator (coding, commissioning, or troubleshooting and maintaining industrial control systems).

What we offer

• A budget of 16,66% (holiday allowance and year-end bonus) of your gross salary, yours to spend or to save monthly
• A full-time employment of 40 hours per week
• Your own place in a close-knit and expert team with an employer that stimulates growth and personal development
• Good accessibility by public transport and we provide private parking
• Sound pension provision.

Seniorities, Employment type, Job function, Industries

• Seniority level: Not Applicable
• Employment type: Full-time
• Job function: Management
• Industries: Pharmaceutical Manufacturing

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