Exp Sci Biotherapeutics RD

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Position summary

In this role you will be part of the ELM team within the Lab Operation pillar.

The Equipment Life Cycle & Automation Specialist is a handson individual contributor responsible for managing laboratory equipment lifecycle activities supporting laboratory data systems and ensuring data integrity and technical specifications are met for development GxP operations. The role partners with several internal / local departments and external vendors to deliver validated connected and fitforpurpose lab solutions.

Key responsibilities

- Coordinate equipment introduction and lifecycle activities including coordination of IQ/OQ/PQ decommissioning change control input and documentation.

- Maintain and support laboratory data system methods and reporting in collaboration with scientists.

- Translate data integrity (DI) and regulatory requirements into technical specifications; ensure systems comply with development GxP risk profiles and DI expectations.

- Provide technical input; review vendor deliverables and ensure timely complete submissions.

- Collaborate with several departments to manage access rights audit trails connectivity and cybersecurity considerations for connected lab systems.

- Troubleshoot instrument/integration issues and coordinate escalation as needed.

- Maintain an accurate inventory and status overview of connected lab systems.

Required qualifications & experience

- Bachelor in Life Sciences or Computer Sciences or equivalent.

- Minimum 4 years relevant industry experience in pharma/biotech (GxP environment).

- At least 2 years handson experience with equipment validations (IQ/OQ/PQ).

- Strong working knowledge or demonstrated affinity with 21CFR Part 11 EU GMP Annex 11 and ALCOA principles.

- Demonstrated ability to work with stakeholders to translate use cases into technical/validation requirements.

- Excellent written and verbal skills in English (required); Dutch desirable.

Technical skills:

- Waters Empower (chromatography data system) Strongly preferred.

- Affinity with (laboratory) data acquisition and processing software use of database systems (and visual reporting considered as a plus

- Cybersecurity awareness for lab assets and ability to coordinate with stakeholders.

- Communication & stakeholder management Required (effective liaison with stakeholders).

Nice to have:

- Handson lab experience operating HPLC/CE/cSDS or similar analytical systems

- Experience with risk/impact assessments in development programs and participation in audits.

- Familiarity with LIMS BIOVIA or other lab platforms.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is:

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.