Manufacturing Process Specialist

Johnson & Johnson•Gurabo, PR

35d

About The Position

At Johnson & Johnson,â we believe health is everything. Our strength in healthcare innovation empowers us to build aâ world where complex diseases are prevented, treated, and cured,â where treatments are smarter and less invasive, andâ solutions are personal.â Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.â Learn more at https://www.jnj.com About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Manufacturing Process Specialist to join our team in Gurabo, PR. We would love to hear from you if you are interested in this position. Summary: Will be responsible to make significant improvements in the Operations areas using practices and methodologies, Process Excellence tools, and Key Performance Indicators. This includes 1) leading, planning, and execution of projects, 2) mentor projects, 3) crafting a continuous improvement and lean culture. Works with support groups and transactional areas to reduce cost, reduce inventory, and build flow aligned to customer demand. Works with Business Excellence to develop and maintain current and future state Value Stream Maps (VSM). Prioritizes and tracks the progress of projects and initiatives. Provides training on Process Excellence methodologies and practices, supports Process Excellence certification, supports statistical analysis, and contributes to people engagement. Acts as a change management agent for new initiatives.

Requirements

A minimum of a Vocational, Certificate, Technical or Associates degree is required, Bachelor's or higher degree in Pharmacy, Engineering, or related Science is preferred.
At least six (6) years of pharmaceutical or related proven experience performing scientific, manufacturing activities, and/or Project Management.
Knowledge in Good Manufacturing Practices (GMP), Documentation Rules, Regulatory Compliance, Occupational and Environmental Security and ability to follow the documentation for the execution of batch records, SOPs and work instructions.
Knowledge in controlled substance products controls and Drug Enforcement Administration (DEA) audits from packaging/MFG Operations standpoint.
Flexibility to change shifts, work extra time, weekends and holidays according to the business needs.
Fluency in both English and Spanish languages (written and verbal)

Nice To Haves

Good skills in the use of computerized programs such as: SAP, ePES, Tru Vault, Microsoft Word, Excel, Power Point and Outlook.
Good analytical and diagnostic skills.
Technical writing skills in English and Spanish
Strong leadership, time management and project management skills

Responsibilities

Accountable for controlled substances inventory/transactions Batch Record/Logbooks review.
Provides technical support in continuous improvement and transformational project planning, development, and implementation.
Defines strategies for product cost optimization covering areas such as waste reduction, changeover, and cycle time reduction, streamline product flow and others.
Identifies key resources for each phase of the project, including team members and contractors as needed.
Identifies and facilitates activities required for projects completion. Prepares project plan and provide follow-ups to critical achievements to ensure on time completion.
Supports the preparation of technical documentation related to the projects, including strategic plans, protocols, and reports.
Coordinates Gemba walks, keeps track of actions identified, participation and progress.
Supports the Managers and Supervisors in the day-to-day process activities.
Documents all work-related activities in a clear and accurate manner that must align with established company and regulatory compliance requirements.
Participates in projects, programs, committees, and special activities that the company promotes geared toward establishing its strategic goals.