Sr Manufacturing Process Owner

8427-Janssen Cilag Manufacturing, LLC Legal Entity; Gurabo (PR); On-site; USD 77,000 - 123,000; Full time

Benefits offered by this job

Vacation – 120 hours per year

Sick time – 40 hours

Job summary

Johnson & Johnson is seeking a Sr. Manufacturing Process Owner in Gurabo, Puerto Rico, to oversee end-to-end manufacturing processes and ensure efficiency and compliance with cGMPs. You will lead cross-functional teams, drive CAPAs, and optimize performance metrics.

The role requires strong leadership, excellent communication, and a deep understanding of GMP and regulatory guidelines. A Bachelor’s degree and 6–8 years in pharma manufacturing are expected, with prior supervisory experience.

Qualifications

• Bachelor's degree in business, science, pharmacy, engineering, or related field.
• 6–8 years pharmaceutical industry experience.
• 3+ years as a supervisor or Manufacturing Process Owner.
• Experience developing people and flexible workforce strategies.

Responsibilities

• Ensure adequate personnel, equipment, and materials for production planning.
• Monitor production to prevent deviations and implement CAPA.
• Audit floor for cGMP, housekeeping, and EHS compliance.
• Analyze process data to identify improvement opportunities.
• Develop strategic decisions aligning with objectives.

Skills

Manufacturing leadership

Process improvement

GMP compliance

Quality systems

Problem solving

Cross-functional collaboration

Data analysis

Auditing

Communication

Education

Bachelor's degree in business, science, engineering, or related field

5+ years in pharmaceutical/manufacturing

Supervisor/leadership experience

Tools

CMC

GMP

Job description

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com

Job Function

Supply Chain Manufacturing

Job Sub Function

Manufacturing Process Improvement

Job Category

Professional

Job Posting Locations

Gurabo, Puerto Rico, United States of America

Position Overview

The Sr. Manufacturing Process Owner plays a crucial role in the implementation of Business Process Management. This experienced professional is responsible for overseeing and managing the end-to-end manufacturing processes, ensuring that they meet established efficiency and effectiveness strategies. The incumbent must possess technical expertise and demonstrate a strong understanding of the organization's systems and processes. Additionally, the role requires excellent collaboration and influencing abilities. Strong communication, interpersonal, leadership, teamwork, organizational, planning, time management, and prioritization skills are also essential for success in this position.

Essential Job Duties and Responsibilities

• Ensures that the department has sufficient personnel, equipment, and materials to meet the demand for production planning.
• Monitors manufacturing activities to prevent process deviations and implements corrective and preventive actions.
• Ensures adherence to procedures and controls by regularly monitoring production activities and providing corrective feedback.
• Conducts regular walkthrough audits of the operational floor to ensure compliance with cGMPs, housekeeping, and EHS regulations.
• Monitors and analyzes manufacturing process data to identify opportunities for improvement in the manufacturing areas.
• Develops strategic decisions to ensure processes align with planned objectives, or adjust direction if indicators suggest it’s necessary.
• Ensures that personnel and systems involved in the processes have the necessary knowledge and tools to carry out their activities effectively.
• Identifies and defines appropriate process control and performance indicators to monitor the manufacturing process.
• Monitors manufacturing activities to identify and reduce potential process risks and implements appropriate corrective and preventive actions.
• Continuously monitors ongoing processes and is responsible for troubleshooting and resolving any problems that arise during the manufacturing process.
• Prepares weekly and monthly reports on the results and actions taken in the implemented manufacturing process.
• Supports strategic alignment with other area owners.
• Manages commitments, CAPA (Corrective and Preventive Actions), Change Control, and other process quality systems.
• Provides support for manufacturing investigations, including root cause analysis for complex cases.
• Keeps updated knowledge of cGMP regulations, FDA/Other Regulatory Guidelines, and applies these principles in the investigation process and issuance of final reports.
• Participates in the review of APR recommendations and change proposals to assess their implementation in relation to the product/system, ensuring that there is appropriate documented evidence to support the changes/recommendations and that any potential impact on product quality can be anticipated or mitigated.
• Provides technical support to Area Managers and Supervisors on GMP-related aspects of manufacturing/packaging/laboratory processes, such as investigations, complaints, deviations, CAPAs, changes, and APRs.
• Provides technical support to Area Managers and Supervisors during GMP- related audits, including internal audits.
• Participates in the writing, review, or revision of procedures to ensure consistency with current practices, cGMPs, guidelines, policies, industry trends, and best practices.
• Keeps management informed of events that may impact product quality and timely disposition.
• Participates in troubleshooting processes/products to maintain desirable product unit yields and recommends and implements measures to improve methods, equipment performance, floor layouts, yields, and product quality.

Qualifications Required

• Bachelor's degree in business administration, science, pharmacy, engineering, or a related field.
• At least six (6) to eight (8) years of experience in the pharmaceutical industry.
• At least three (3) years of experience as a supervisor or Manufacturing Process Owner.
• Proven experience and a track record in developing people, aligned with Flexible Workforce Strategies and Career Ladder Structures.
• Preferred: An MA or MS degree is preferred.
• Strong leadership, interpersonal, and communication skills at all levels of the organization.
• Performance-based exceptions may be considered if the candidate demonstrates exceptional technical knowledge, skills, and abilities.

Required Skills

Agile Manufacturing, Benchmarking, Business Valuations, Chemistry, Manufacturing, and Control (CMC), Coaching, Communication, Financial Competence, Good Manufacturing Practices (GMP), ISO 9001, Plant Operations, Problem Solving, Process Control, Process Improvements, Program Management, Quality Management Systems (QMS), Quality Standards, Quality Systems Documentation, Standard Operating Procedure (SOP), Time Management

Pay Transparency

The anticipated base pay range for this position is : $77,000.00 - $123,050.00

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year
• Additional information can be found through the link below. For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

About Johnson & Johnson

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/. Do Not Sell or Share My Personal Information Limit the Use of My Personal Information