Quality Assurance CSV Engineer

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 https://www.jnj.com

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Beerse, Antwerp, Belgium, Olen, Antwerp, Belgium

Job Description:

QA CSV- Quality Assurance Computer System Validation Engineer

You 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.

Job Description:

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.

Job Qualifications:

• 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)