Quality Engineer – QA Equipment Qualification

Description

You will join the quality engineering team at the Innovative Medicine Supply Chain site in Geel, Belgium, as a Staff Quality Engineer covering QA Equipment Qualification. The role sits within a QA department.

The site is the company's Centre of Excellence for developing and manufacturing small molecule active pharmaceutical ingredients (SM-APIs) and drug product intermediates. Its quality unit oversees these products and gives final release, supporting the site as a Launch and Grow location.

You will be the subject matter expert for quality oversight of production equipment during Atlas, a multiyear capacity expansion. Atlas replaces and expands reactors, adds centrifuges, dryers and filter dryers, and modifies utilities and infrastructure inside existing production buildings to add multipurpose capacity and meet evolving compliance expectations.

The team focuses on technology, qualification and validation, automation, and continuous improvement. Development happens on the job, through e-learning and through projects and programs aimed at building on your strengths.

Responsibilities

• Make sure every equipment qualification regulatory requirement is met across the full lifecycle: concept, project, operation and retirement.
• Review and approve qualification documents, including SOPs, user requirements, risk analyses, qualification plans, tests, changes and deviations, so they meet regulations, guidelines, company policies and standards.
• Keep up with international laws, guidelines and changes affecting qualification through courses, conferences, seminars, internal and external benchmarking and literature, and apply that knowledge to improve equipment qualification.
• Represent the site as spokesperson during audits and inspections, and prepare for them.
• Plan and follow up on internal and external audits to confirm regulatory compliance.
• Work with engineering, operations and other teams when new systems and processes are introduced.
• Advise on and support qualification activities for new projects, and protect cGMP requirements. Sit on multifunctional teams that deliver cross-department goals.
• Make sure innovation projects are designed and delivered within the GMP quality framework, with change controls, investigations and CAPAs handled accurately and on time.

Requirements

• A master's degree in a scientific field or equivalent experience.
• 4 to 6 years of experience in the pharmaceutical or chemical industry.
• Working knowledge of cGMP and qualification compliance, including 21 CFR Parts 211, EU Directive 2003/94/EC, annex 11 and 15, ICH Q7, GAMP and data integrity guidelines.
• Hands-on experience with equipment qualification.
• Fluent written and spoken English and Dutch, and the ability to work well with diverse partners.
• A strong sense of ownership and quality, and the ability to meet commitment deadlines.
• Strong analytical thinking, and the flexibility to work under time pressure.
• The ability to make risk-based decisions and understand the business effects of quality decisions.
• The ability to work accurately and proactively across organizational boundaries as one team.
• An understanding of AI concepts and frameworks, awareness of responsible and ethical AI use, and experience writing effective prompts to improve efficiency and productivity.
• Preferred skills: coaching, consistency, controls compliance, critical thinking, data savvy, engineering, financial competence, Good Automated Manufacturing Practice (GAMP), ISO 9001, lean supply chain management, leveraging information, process improvement, quality control testing, quality standards, quality systems documentation, quality validation, applying STEM, and being technologically savvy.

Conditions

This is a contract of indefinite duration based in Geel, Belgium.

The anticipated base pay range is €72,500.00 to €115,230.00.

The company welcomes applicants of all backgrounds and respects every employee's diversity and dignity.

Benefits

• An annual bonus with a set target percentage of pay, based on pay grade and location and on company and individual performance in the previous calendar year, or sales commissions where applicable.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical and mental health.
• Service anniversary and recognition awards.
• Eligibility for insurance plans, which may extend to dependents depending on the plan and location.
• Extra-legal benefits including meal vouchers, an additional pension plan and hospitalization insurance.
• Benefit details and amounts may vary by location and are subject to change, and are provided for information only.