At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
QualityJob Sub Function:
Quality AssuranceJob Category:
ProfessionalAll Job Posting Locations:
Beerse, Antwerp, BelgiumJob Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
QA CSV- Quality Assurance Computer System Validation EngineerYou have a passion for Quality, love well-functioning systems and you are eager to gain in-depth knowledge of the quality & compliance requirements in this field? Then this position is waiting for you!
We as QA CSV group belong to the Quality organization of Johnson & Johnson Innovative Medicine Supply Chain (IMSC) and are responsible to ensure the quality and compliance of different systems on the J&J Belgian Campus (including commercial and clinical activities in Beerse, Olen and Geel).
To strengthen this team, we are looking for a Quality Assurance Computer System Validation Engineer (M/F/X), located mainly in Beerse Belgium, with focus on IMSC Beerse/Olen systems. The function will allow up to 2 days per week work at home.
Your main responsibilities:
- Assure that all Computer System Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems (concept, project, operational and retirement phase).
- Act as Process Owner for Computer System Validation management.
- Review and approve CSV documents such as SOPs, user requirements, risks analysis’s, validation plans, test scripts, changes, deviations etc…) in order to maintain compliance to regulations, guidelines, J&J policies and standards.
- Maintain a current knowledge of international laws, guidelines and new evolutions related to CSV through courses, conferences, seminars, internal and external benchmarking and literature studies. Implement this knowledge to maintain and improve CSV at J&J IMSC.
- Prepare for audits and inspections by regulatory agencies, customers and internal compliance team.
- Be the spokesperson for CSV related matters during audits and inspections.
- Perform and follow up on internal and external audits to accomplish regulatory compliance.
- Cooperate with engineering, IT and other teams for the introduction of new systems and processes and for the complete life cycle of the equipment.
- Give advice and support for the preparation of CSV related activities and guard the cGMP aspects in new projects. Be a member of multi-functional teams to realize cross-departmental objectives.
- Master scientific degree or equivalent experience.
- 3 years’ experience in the pharmaceutical industry.
- Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; Eudralex 4, EU Directive 2003/94/EC, EU Directive 2017/1572 and annex 11; GAMP, Data Integrity Guidelines)
- Experience with Computerized System Validation.
- Strong ownership and quality attitude. You are able to deliver on commitment timelines.
- Ability to make risk-based decisions. Understands the business implications regarding quality positions and decisions.
- Fluent in verbal and written communication in English and Dutch and are able to connect with diverse partners.
What is in for you?
You work in a dynamic team in an international and innovative environment with room for personal and professional development. You have the possibility to gain experience in a variety of tasks with focus on your talents.
Your work is of high importance to supply products to our patients. You work in a company that cares for the world and its people!
The employers of Johnson & Johnson also value diversity, equity, and inclusion. We are committed to forming teams with varied strengths that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Required Skills:
Preferred Skills:
Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, Human-Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
The anticipated base pay range for this position is:
€72’500.00 - €115’230.00Benefits:
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 location’s 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.
Skills Required
- Master scientific degree or equivalent experience
- 3 years' experience in the pharmaceutical industry
- Knowledge of cGMP/CSV compliance
- Experience with Computerized System Validation
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
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