SENIOR COMMISSIONING AND QUALIFICATION ENGINEER

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.
Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences That is why we in Ireland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.
No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”! Janssen Ringaskiddy, Overview.
Janssen Sciences Ireland UC established operations in Ringaskiddy, Co.
Cork in , on a 100-acre site with an investment of €500 million.
For more than 25 years, Janssen has been a global leader in the field of biomedicines, pioneering monoclonal antibody technology - a ground-breaking approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
In , Janssen Sciences Ireland UC invested a further €300 million in the expansion of its manufacturing plant and created 200 additional jobs.
The facility in Ringaskiddy is operational, producing biomedicines for the treatment of immune related diseases and new, innovative cancer treatments.
An additional €150m investment in expansion was completed in .
The Johnson & Johnson Family of Companies makes a big difference in the health and well-being of people every day.
We have more than 250 operating companies in 57 countries employing approximately people.
Our consumer products and medical devices and diagnostics impact the state of health care for patients, doctors, and nurses around the world.
Currently for our Cork Biopharma Organization Janssen, we are looking for highly motivated candidate for the position of.
Senior Commissioning and Qualification Engineer Job Description.
Reporting to the Site Engineering C&Q Manager the Senior C&Q Engineer will support the execution of the Site’s Commissioning and Qualification Requirements.
This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements.
Duties & Responsibilities Coordinate the C&Q team ensuring policies and procedures are deployed which reflect best practice in the industry.
Provide input into all aspects of validation i.
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from design through to the commissioning and qualification execution phases Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
Develop commissioning and qualification documentation as required (e.
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specifications, plans, protocols, procedures).
Provide technical leadership and supports execution of Engineering Capital Projects Support training within the C&Q team so that the team functions at a high-performance level.
Co-ordinate and support project delivery process from a C&Q perspective ensuring the FPX (Flawless Project Execution) process is used to drive deployment.
Support Regulatory Inspections to provide technical knowledge of the C&Q processes.
Develop procedures used in commissioning and qualification of GMP equipment.
Initiate and implement change control activities in accordance with site procedures.
Coordinate with the Technical Operations group to ensure alignment on technical standards Research business and technical issues to establish what is being done and where improvements are possible.
Ability to work in a team, coordinate and enthuse colleagues and consultants.
Strong initiative and the ability to proactively identify required tasks.
An organised approach to working, task prioritization and time management.
Awareness & understanding of applicable company procedures Qualifications Key Competencies Required Excellent interpersonal and communication skills.
Ability to operate as part of a team.
Attention to detail.
Good problem-solving skills.
Results and performance driven.
Adaptable and flexible.
Serve as a role model for making Credo-based decisions, helping others understand the value of Credo-based decisions.
Support the creation of a believing, reciprocal, and ethical work environment that positively gives to employee engagement.
Evaluates and communicates significant risks, takes appropriate action, and demonstrates an awareness of the highest standards of quality and compliance.
Take accountability for their performance and development alongside supporting talent acquisition and the development of others.
Demonstrates different perspectives, backgrounds, and talent to generate effective ideas or solutions and engage in open and constructive conversations, supplying to high-performance teams.
Understands how own work impacts the enterprise and use understanding to make effective decisions and take actions and lead priorities effectively to deliver expected results.
Qualifications Essential BSc qualification (Science or an Engineering related discipline) At least 5 -10 years’ experience and a proven track record within a cGMP regulated environment Experience of commissioning & qualifying GMP systems.
Strong knowledge of Commissioning and Qualification Regulations and Standards.
Planning and organizing skills Excellent PC, interpersonal and influencing skills Excellent written and oral communication skills and strong attention to detail.
Desirable Experience within a BioPharma environment.
Experience of Digital validation systems Supervisory/Project Lead experience.
Ability to work under pressure and meet deadlines.
Ability to work in a team, coordinate and enthuse colleagues and consultants.
Strong initiative and the ability to proactively identify required tasks.
An organised approach to working, task prioritization and time management.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.