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Essential Job Duties and Responsibilities

Operates as an established support individual contributor that executes tasks that are typically routine, with limited deviation from standard practice. Provides support for internal groups in the Advanced Therapies Pilot Plant Operations teams. Follows administrative processes to ensure accuracy, timeliness, and quality of deliverables. Maintains high standards of professionalism, efficiency, personal communication, discretion, and independent judgment.

Completes tasks for the support function of the Advanced Therapies Pilot Plant Operations teams, and follows administrative processes to ensure accuracy, timeliness, and quality of deliverables. Adheres to standard operating procedures to support initiatives, project plans, and key milestones related to the processing of ingredients and/or pharmaceutical products. Helps with day-to-day activities and resources and escalates any concerns or issues to leaders to maximize successful business results. Keeps record of process improvements to continually enhance program quality, cost, and scheduling. Maintains front-line knowledge of Good Manufacturing Practices (GMP) and regulatory issues to efficiently manage project tasks in accordance with internal and external regulations and procedures.

Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.

Within the Advanced Therapies Pilot Plant Operations (ATPO) team, this role typically includes:

• Carry-out experiments in the lab and pilot plant.

• Working with scientists in Process Development to learn more about the unit operations

• Writing and/or reviewing the GMP process documentation (SOPs, WI, BRs, etc.) required to perform the process in GMP

• Doing water runs and training runs to ensure production readiness

• Ensuring production areas, materials and equipment are all ready for production activities

• Performing engineering and GMP production runs according to protocols or SOPs, including accurately recording all process, equipment and material data

• Coordinating with other departments (QA, logistics, QC, EVM, ...)

• Proactively identify and work on resolving problems that occur in production

• Supports Non-Conformances by investigating deviations

• Perform related duties as assigned by supervisor

• Maintain compliance with all company policies and procedures.

Minimum Qualification

• BSc, MBO (level 4) or HBO degree, or equivalent in the field of Microbiology/ Life Sciences/ Engineering.

• Excellent verbal and written communication skills in English

• Excellent computer proficiency e.g. MS Office

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.