Senior IT/OT Automation Engineer

Brabant
5500.00 - 7500.00
40 hours
1 year, contract to hire with client
Bachelor degree

Client

Our client is a leading consulting and engineering firm in pharma, food and chemistry.

Requirements

Strong knowledge and understanding of automation systems, computer system validation, and regulatory requirements in the pharmaceutical industry.
Detail-oriented, with excellent problem-solving and analytical skills.
Proficient in project management methodologies and tools.
Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
Specific Technical Competencies: Siemens TIA Portal, SCADA system, Win-CC, EMS, BMS, AD/LDAP, VLAN

What do you get?

Pension entitlement (15.9% employer contribution, 7.5% employee contribution)
Collective WGA / WIA insurance
NBBU collective labour agreement through equal remuneration
25 holidays days
8% holiday allowance
100% payment in case of illness after one waiting day
Travel allowance per kilometer or through public transport

Duties

The senior ITOT Automation Engineer will be required to oversee the OT scope of Semi-automated and Automated lines being deployed and operated across the RLT Network. In this role, will oversee a team of Automation Specialists responsible for managing the automation and computer system validation for an automated manufacturing line used in radioligand therapies.

Responsibilities

GMP Computerized Systems Administration of GxP lab system software, including installation, backup, archival of data and general data management
GMP Computerized Systems Validation
Support with the implementation- and validation of new computerized systems. Including writing and review of validation protocols and reports.
Support end users in day-to-day operation of software/systems and able to identify computer related issues; troubleshoot, identify and complete or coordinate deviation, change control and/or corrective actions
Maintain and understanding of new technology and their application to the department.
Collaboration with the end users within the department to enable their efficient use of the laboratory system
Ensure that adequate standards are maintained, communicated and effectively implemented for all systems and associated computer infrastructure
Consult and advise computer systems projects on the correct application of internal and external regulations
Audit computerized systems at the site and monitor the implementation of corrective and preventive action plans.
Ensure that the internal regulations are in line with up to date regulatory requirements.
Supporting the change management process for new software or software updates: creating design specification, feedback on software setup on the Lonza OT environment etc.
Familiarity with Cell and Gene Therapies cGMPs, GAMP and basic validation practices (IQ/OQ/PQ)