Vacature Operator 3

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Equal Employment Opportunity Posters and GINA Supplement.

Operator 3, Manufacturing/Production

• Job Title Operator 3, Manufacturing/Production
• Function Operations
• Sub Function Production
• Location Leiden, South Holland, Netherlands
• Date Posted Dec 19 2023
• Requisition Number 23W

Description

Department API Clinical Manufacturing
Supervisor Clinical Manufacturing Operations Manager
Position Title Manufacturing Operator

Job Scope
We are seeking a skilled and detail-oriented Manufacturing Operator to join our Clinical Manufacturing team. The Manufacturing Operator will be responsible for executing manufacturing processes in compliance with established Standard Operating Procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory guidelines. The successful candidate will contribute to the production of clinical trial material, enabling the advancement of new therapies for various medical conditions.
They should be flexible and able to adapt to new situations with a calm, 'can do' attitude. They will uphold and embody our CREDO principles and encourage this in others, including our commitment to strengthening and protecting the diversity, equality, and inclusivity of our teams and communities. We are looking for a teammate who is open to giving and receiving transparent and constructive feedback, learns from mistakes and takes the initiative to improve.
The manufacturing operator should have an eye for innovation and be able to recommend improvements for existing techniques, processes, systems, and equipment. They also understand the annual company, division, and team goals and have a plan to achieve these goals on a personal and team level. They are driven to proactively achieve business goals.

Key Responsibilities
• Follows day-to-day objectives and performs routine production processes according to SOPs.
• Monitors production progress and ensures compliance to standards.
• Identifies deviations and escalates appropriately and on time.
• Fully supports the business needs by working assigned shift pattern and schedule.
• Ensures success with 100% compliance with GMP and EHS&S standards.
• Documents all manufacturing activities, observations, and data accurately and in a timely manner using electronic batch records and other designated documentation systems.
• Completes batch documentation review with a "right the first time" mind-set.
There are 3 distinct manufacturing areas, and each has unique activities outlined below:
Cell Culture/Fermentation Activities
• Media preparation, filtration, and storage.
• Employs strict aseptic technique to all cell culture activities (e.g., vial thaw, culturing, and inoculation)
• Works with Biosafety Cabinet (BSC) and incubators
• Can assemble and disassemble various cell culture equipment including wave rockers, bioreactor vessels, and recovery equipment such as POD filter holder and centrifuges.
• Uses DeltaV and Unicorn control systems to execute, monitor, and control processing steps.
• Performs continuous monitoring of cell culture process including daily bioreactor monitoring and sampling (including non-routine samples).

Purification Activities
• Column chromatography
• Solvent detergent treatment
• Virus filtration
• Ultrafiltration/Diafiltration
• Final Filtration (filling product in LAF-hood)
• In Process Testing (sampling, Solo VPE, pH, conductivity, osmolality, spectrophotometer)
• Assembly and Disassembly of equipment (SUM's)

Bioprocess Supply Activities
• Calibration and monitoring of equipment (pH meter, conductivity, osmometer)
• Monitoring and control of the working area specifications during process activities.
• Control of documentation (logbooks)
• Basic asset care: ensure housekeeping (5S), maintenance and organization of the rooms and equipment (Operations Inspection Readiness)

Qualifications & Requirements
• Bachelor's degree or MLO and 2 years GMP experience or training.
• Experience with project management and process excellence a plus (LEAN, Six Sigma, CAPM, etc).
• Experience with automated production systems and PLC controls
• Familiarity with software such as SAP, eLIMS, TruVault, and TrackWise
• Ability to communicate in English both in writing and orally.
• Ability to follow complex procedures, work independently, and prioritize tasks effectively.
• Excellent communication skills and the ability to work collaboratively within a team.

Diversity, Equality & Inclusion
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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued 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"!

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

：1-800-458-1653

Contact Information: 1-800-458-1653

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Functie:	operator
Startdatum:	25-12-2023
Ervaring:	Ervaren
Educatielevel:	HBO
Contracttype:	Vast
Salaris:	onbekend – onbekend
Uren per week:	1 – 40

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