Ops Investigator

We are looking for 1 Ops Investigator for a project of 6 months, potentially extended with 6 months depending on business needs and performance.

(Preferable) Start Date: August 1st 2026 (ASAP)

• Lead and support (cross-) departmental investigations and risk assessments by applying appropriate root cause analysis tools and risk assessment methodologies in accordance with cGMP regulations and internal quality systems.
• Identify appropriate and strong CAPA actions and effectiveness checks linked to non-conformances, and lead, support, and execute the implementation of CAPA actions.
• Build strong partnerships in a matrixed environment by liaising with different (cross-) functional teams such as Operations, QA, MS&T, QC (IPL), Supply Chain, Engineering, as well as external collaborators to solve issues, drive improvement, and ensure consistent product quality.
• Operate with a high degree of independence, seeking managerial input for complex or non-routine matters.
• Provide support during internal and external audits, including preparation of documentation

Required profile:

• A minimum of a Bachelors degree in (bio)-Engineering, Science, Pharmacy or related field or equivalent experience required.
• 1-3 years of experience with handling and writing non-conformances/investigations within a cGMP or ATMP environment in the biotech/biopharma industry. Prior experience in manufacturing or quality is considered an advantage.
• Excellent scientific writing skills with attention to detail.
• Excellent communication skills.
• The candidate must be able to manage shifting priorities, handle multiple tasks simultaneously, and be flexible to go the extra mile to meet critical deadlines in a fast paced and dynamic environment.
• Flexible mindset capable to deal with ambiguity, and respond quickly, energetically, and enthusiastically to changes.
• Positive and pro-active attitude, able to work in a team environment

HARD SKILLS:

• GMP/ATMP
• Writing of Deviations / Deviaties / Afwijkingen / NCs / Non-Conformances / Events / QARs / QI's.
• Writing Impact Assessment / Risk Assessment in the framework of a deviation.
• Other preferred: QA experience

SOFT SKILLS:

• High level of ownership / Go-getter
• High level of flexibility (due to changing environment + rapidly changing priorities)
• High level of stress-resistance (fluctuating workload + peaks of high workload)
• Stakeholder management
• Knows how to communicate with higher management.
• Communicative / open communication style (awareness trainings / interviews)
• Team player
• Scientific writing

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
• Versnel je carrière met een helder groeipad, coaching en mentoring ter ondersteuning.
• Werk in een dynamische en ondersteunende omgeving waar je echt het verschil kunt maken.
• Werk waar en wanneer je het beste presteert voor een ideale werk-privébalans.
• Kies een flexibele mobiliteitsoplossing, van een bedrijfswagen tot een openbaar vervoer abonnement.
• Bouw je netwerk uit en beleef onvergetelijke momenten tijdens exclusieve events en afterworks.
• Breid je vaardigheden uit met externe opleidingen en onze in-house Pauwels Academy.
• Werk aan uitdagende projecten met toonaangevende klanten in Life Sciences, Engineering & Digital.
• Grijp kansen op elk niveau, van een sterke start tot doorgroeimogelijkheden en samenwerking met experts.