(Empower) Automation Specialist

Location: Randstad Area, Netherlands (Hybrid)

Employment type: Full-time, 1-year contract with the possibility to extend

About the role

Do you have demonstrable experience and affinity with analytical methodologies in combination with automation? Are you ambitious and eager to develop yourself as an Automation Specialist in an international biotechnology company?

Our client offers an exciting opportunity within its QC Laboratories.

The test laboratories are organized based on specific techniques and areas of expertise, and all laboratories are supported by the Automation team.

We are seeking an experienced Automation Specialist with a strong affinity for analytical methodologies and software assurance (CSA). In this role, you will deliver and build automated methods in Empower using custom fields and provide documented evidence that systems and methods are working as intended, for example through IQ, OQ, and PQ protocols.

You will act as the Subject Matter Expert for automation topics, including data integrity, the introduction and maintenance of software methods, and laboratory robotics. You will help ensure GMP compliance while supporting LEAN initiatives across the team and its processes.

Key responsibilities

• Lead the technical implementation of new Empower projects in collaboration with cross-functional teams. Systems range from HPLCs, UPLCs to PA800s analytical instruments.
• Implement and maintain Empower solutions and identify opportunities for paperless workflows.
• Create and maintain administrative, technical installation, and maintenance procedures.
• Own data integrity practices, including backup strategies and disaster recovery planning.
• Provide timely support and troubleshooting for computerized system issues.
• Ensure software implementations meet 21 CFR Part 11 compliance requirements.
• Participate in laboratory systems initiatives and projects in cooperation with the global organization and in alignment with business needs.
• Perform software validation and deliver validated methods to laboratories to enable new testing approaches for new products.
• Support and troubleshoot day-to-day challenges as part of the support team.

Required qualifications

• Bachelor’s degree (HBO) in Life Sciences, Computer Science, or equivalent experience in a similar role.
• A minimum of 2 years of experience in the pharmaceutical industry with GMP and automation responsibilities.
• Hands-on experience in software development and validation; laboratory experience is a plus.
• Experience with Empower in a GxP environment, preferably including custom fields.
• Strong analytical thinking, technical problem-solving, and planning and prioritization skills.
• Proven ability to engage stakeholders and build productive relationships across all organizational levels.
• Excellent written and verbal English; Dutch is desirable.
• Proactive and able to work independently, take initiative, and produce protocols, reports, and procedures.

Desirable (nice-to-have)

• Experience with one or more of the following systems: SoftMax Pro, SDMS, Deskman, LIMS, 32 Karat, or Comet.
• Familiarity with GAMP 5 and 21 CFR Part 11.
• Lean or Six Sigma experience.
• Experience with Computer System Validation (CSV) in a GxP environment.

What we look for in a candidate

• A self-starter who can translate business needs into reliable technical solutions.
• Strong documentation skills with close attention to data integrity and regulatory requirements.
• A collaborative mindset and willingness to support global projects.