Manufacturing Process Specialist

J&J Family of Companies • Gurabo, PR • 4d ago

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?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.?Learn more at https://www.jnj.com

Job Function:

Supply Chain Manufacturing

Job Sub Function:

Manufacturing Process Improvement

Job Category:

Business Enablement/Support

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

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.

Key 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.

Qualifications:

Education:

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.

Experience and Skills:

Required:

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)

Preferred:

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

Other:

My require up to 10% domestic travel

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Agile Manufacturing, Chemistry, Manufacturing, and Control (CMC), Communication, Data Gathering Analysis, Detail-Oriented, Document Management, Goal Attainment, Good Manufacturing Practices (GMP), Health, Safety, and Environmental (HSE) Management, Issue Escalation, Plant Operations, Problem Solving, Process Control, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Report Writing, Time Management

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