Commissioning & Qualification Engineer-1705614712W
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world. Our research and development center develops products for a wide range of disease areas, such as mental disorders, neurological problems, infectious diseases, immunological disorders, cancer, and cardiovascular and metabolic conditions.
"We are Janssen. We collaborate with the world for the health of everyone in it."
Janssen Pharmaceuticals (Janssen Supply Chain Beerse), a Johnson & Johnson company is recruiting for a Commissioning & Qualification Engineer within the Engineering & Maintenance department (EMa). The Commissioning & Qualification Engineer will report directly to the Sr. Engineering Manager.
The Commissioning & Qualification Engineering Department is accountable for:
* Commissioning A well-planned, documented and managed engineering approach to the start-up and turnover of facilities, systems and equipment to the End-User that results in a safe and functional environment that meets established design requirements and stakeholder expectations.
* Installation Qualification (IQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality adhere to approved specifications (e.g., construction, materials) and are correctly installed.
* Operational Qualification (OQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality operate as intended throughout all anticipated ranges.
* Performance Qualification (PQ) The documented verification that all aspects of a facility, utility or equipment that can affect product quality perform as intended meeting predetermined acceptance criteria.
of all manufacturing equipment (sterile & non-sterile) within the Janssen Supply Chain in Beerse and Olen.
The Commissioning & Qualification Engineer:
* Is responsible to maintain the qualification status of systems in support of new, transferred and existing products through definition & maintenance of contemporary methodologies & standards.
* Supports the Commissioning & Qualification Engineering Department in providing documented evidence that all equipment and utilities used in/by/for JSC are qualified and remain in a state of control so that they deliver processes and products that comply to regulatory and business specifications.
* Is responsible for review of System Qualification documents.
* Is responsible for writing and executing qualification protocols, tests and -reports based on user, quality, technical and functional requirements and other relevant information as delivered by the project team. If required, he/she will also assist the project team in writing these (project) documents.
* Act as Technical Owner within the JSC Beerse Organization
* Steers under minimal guidance specialists and contractors within own discipline and/or responsibility area
* Participates in the development of global standards/guidelines, reviews local standards/guidelines
* Prepares for internal and external inspections and acts the spokesperson and Subject Matter Expert during audits and inspections, as pertains Qualification Engineering topics.
* Based on expertise, makes strong recommendations on investigations, investments or projects.
* Internal & external networking
* Work experience in pharmaceutical industry, preferred
* 1+ year of experience in commissioning & qualification of pharmaceutical manufacturing equipment
Technical Skills, Knowledge and Qualifications:
* University Master Degree in (Bio-)Engineering or Science
* Strong technical skills and interest (electrical and mechanical)
* Knowledge of GMP requirements, methodologies, concepts and requirements related to system validation
* FDA - 21 CFR Part 210, 211 Good Manufacturing Practice for Finished Pharmaceuticals
* FDA - 21 CFR Part 11 Electronic records and electronic signatures
Quick learner and good eye for details
Excellent communication and coordination skills
Should have worked with global customers
Ability to work under pressure, flexibility and positive attitude to challenges would be added advantage.
Ability to take decisions
Ability to work independently under general direction
Fluency in written and spoken English and Dutch What's in it for you…? "Caring for the world, one person at a time…"
As an employee, we consider you as our most valuable asset. We take your career seriously.
As part of a technical team in an innovative environment your development is key and our day-to-day responsibility. Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Janssen Pharmaceutica N.V. (7555)