Senior Operations Support Specialist

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Janssen Cilag Manufacturing, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for Senior Operations Support Specialist!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at and follow us @JanssenGlobal. Janssen Supply Group, LLC. Janssen Cilag Manufacturing, LLC is part of the Janssen Pharmaceutical Companies.

The Senior Operations Support Specialist is responsible and accountable for the completion of events and deviations under the guidance of the Sr. Technical Operations Lead or designee. Responsible to provide technical input and performs troubleshooting for the investigation of events and deviations. In addition, the incumbent should support Kaizen events and implementation of process improvement ideas.

As the Senior Operations Support Specialist, you will:

• Be accountable for the completion of events and deviations investigations. Provide support to investigations and resolution of process deviations. Perform troubleshooting of the situation.
• Perform and report metrics related to events, deviations or CAPA's assigned.
• Detect trends related to investigation and complaints required metrics. May initiate and implement Change Controls.
• Assist Area Manager during GMP audits.
• Contact the corresponding supporting departments as Operations (manufacturing/packaging), Engineering (MAM), Facilities/Utilities and/or when needed for support in investigation assessments.
• Recognize and report results that deviate from normal or expected results for routine and non-routine procedures and helping to resolve these problems.
• Provide input for Standard Operating Procedures (SOP's) and Work Instructions (WI) and batch records revisions.
• Determine along with team, corrective and preventive actions using the appropriate root cause analysis tools.
• Participate in projects, programs, and special activities that the company promotes geared toward establishing its strategic goals.
• Perform other duties as delegated by the area management.

Qualifications

Education

• A bachelor's or higher degree is required. Focused degree of Science in Biology, Microbiology, Chemistry, Pharmacy, Engineering, or related field is preferred.
• CAPA Certification is desirable.

Required

• A minimum of a BS and at least 4 years of experience, OR a MS with at least 2 years of experience, OR a PhD with at least 1 year of relevant experience is required.
• Experience in Operations, Technical Operations, Validations, Investigations, and/or related technical support area in the pharmaceutical, biotechnology or related industry
• Good knowledge of Current Good Manufacturing Practices (cGMP's), regulations and validation / technical support methods and procedures
• Technical writing skills
• Proficiency in the use of MS Office applications (Word, Excel, PowerPoint, Outlook)
• Good communication and interpersonal skills. Demonstrate Analytical and Technical skills.
• Must demonstrate Servant Leadership, Diversity, and Inclusion mind-set. Strong skills in collaboration, teamwork, negotiation, influencing and conflict management.

Preferred

• Training and/or experience in Root Cause Analysis, Quality Risk Management, Statistics, and its Applications
• Experience in large molecule - parenteral environment
• Knowledge of the principles, methods, tools, and techniques of project management
• Good knowledge of scientific investigation processes
• Good knowledge of statistics program, Minitab
• Ability to apply root cause analysis, troubleshooting and diagnostic skills

Other:

• Bilingual (English and Spanish), written and orally is required.
• The position works a regular shift, but occasionally may be required to work extended hours, holidays, and weekends.
• This position requires up to ten percent (10%) of travel time.

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.

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