CSV Trainer /Engineer - Validation

Oltera PG; Geel; Hybrid; EUR 36,000 - 43,000; Full time

Benefits offered by this job

Company car

Meal vouchers

Eco vouchers

Home-working allowance

Mobile phone allowance

Health insurance

Group insurance

Hybrid work options

Contract flexibility

Job summary

Oltera PG in Geel is seeking a CSV Trainer who also contributes to client projects. You will design and deliver hands-on CSV training, create practical learning materials, and mentor new joiners while performing validation tasks on real assignments.

We welcome juniors, part-time candidates, and freelancers. Availability for on-site work in Geel with possible hybrid arrangements is expected as project phases dictate.

Qualifications

• Bachelor’s or Master’s in (Bio)Engineering, CS, Chemistry, or similar.
• Practical CSV/validation experience and training/coaching background.
• Hands-on GMP, GAMP 5 and 21 CFR Part 11 knowledge; data integrity interest.

Responsibilities

• Design and deliver practical CSV training programs and workshops (onboarding, IQ/OQ/PQ, GAMP 5, 21 CFR Part 11, data integrity).
• Create training materials: slides, SOP-aligned checklists, hands-on exercises, assessments, and LMS content.
• Mentor and coach new joiners through real project tasks and supervised test execution.
• Prepare and review validation plans, IQ/OQ/PQ protocols and validation reports on project work.
• Execute or support test activities to verify system functionality, data integrity, and compliance.
• Monitor training effectiveness and maintain training records per GMP and client requirements.
• Support audits and regulatory inspections by preparing training evidence and assisting project team responses.

Education

Bachelor’s or Master’s degree in (Bio)Engineering, Computer Science, Chemistry, or similar

Tools

GAMP 5

21 CFR Part 11

Job description

Do you enjoy turning rules into reliable results and turning teammates into confident validators? Join us as a CSV Trainer who also gets hands-on in projects. You’ll train new joiners, create practical learning materials, and still roll up your sleeves to deliver validation work for a client project in Geel supporting a pharmaceutical company. Juniors, part-time candidates, and freelancers welcome.

What you’ll actually do

• Design and deliver practical CSV training programs and workshops (onboarding, IQ/OQ/PQ, GAMP 5, 21 CFR Part 11, data integrity).
• Create clear training materials: slides, SOP-aligned checklists, hands-on exercises, assessments, and LMS content.
• Mentor and coach new joiners through real project tasks and supervised test execution.
• Prepare and review validation plans, IQ/OQ/PQ protocols and validation reports when acting on project work.
• Execute or support test activities to verify system functionality, data integrity, and compliance.
• Monitor training effectiveness and keep training records in line with GMP and client requirements.
• Support audits and regulatory inspections by preparing training evidence and helping the project team respond confidently.

Who we’re looking for

• Bachelor’s or Master’s degree in (Bio)Engineering, Computer Science, Chemistry, or similar.
• Practical CSV/validation experience plus demonstrated training or coaching experience (internal trainer, trainer certification, classroom or technical mentoring).
• Hands-on knowledge of GMP, GAMP 5 principles, and 21 CFR Part 11; strong interest in data integrity.
• Clear communicator in English; Dutch is an advantage but not required.
• Availability to work on-site in Geel as required (hybrid options may apply depending on project phase).
• Open to applicants as employees, part-time employees, or freelancers/contractors — please state your preferred engagement type and availability.

Perks & practicalities

• Starting gross monthly salary of at least €3,500 for junior employees (actual offer for mid/senior hires will be competitive and commensurate with experience).
• Company car and fuel card (employee roles, eligibility per policy).
• Meal vouchers and eco vouchers.
• Home-working allowance and mobile phone allowance.
• Hospitalisation insurance and group insurance (employee benefits).
• Hybrid working options depending on project needs; this vacancy supports an on-site project in Geel.
• Flexible engagement: full-time, part-time, and contractor arrangements can be discussed.
• Freelancers: competitive day rates and flexible contracting arrangements.
• Subject to performance and business needs, contractors may be considered for conversion to an open-ended (permanent/unlimited) employment contract.
• Final terms differ for employees and contractors and will be agreed in writing.
• Whether you are applying as an employee, part-time employee, or freelancer/contractor.
• Your availability to work on-site in Geel and any right-to-work or visa considerations.

HR & legal

We are an equal opportunity employer and welcome applications from all qualified candidates.

Decision are made without regard to any protected characteristic as defined by applicable law.

Right-to-work: Offers are subject to verification of the legal right to work in the relevant country; candidates must provide documentation upon request.

Background checks: Final offers may be conditional on satisfactory background checks, references, and other pre-employment screening as permitted by local law.

Contractor arrangements may include appropriate pre-engagement checks.

Data privacy: Applicant personal data will be processed for recruitment purposes in accordance with our privacy policy.

By applying, you consent to recruitment-related processing of your personal data.

Contact HR for details or data access requests.

Reasonable accommodations: If you require adjustments to participate in the recruitment process, please contact us, we will make reasonable accommodations consistent with applicable law.

Recruitment fraud warning: We will never ask candidates to make payments during recruitment. If you are asked for money, report it to us.

Employment type: All offers will clearly state whether the engagement is employee-based, part-time employee-based, or contractor-based and will include the applicable terms, benefits, and termination conditions.