Job Function:
Supply Chain Manufacturing
Job Sub Function:
Manufacturing Process Improvement
Job Category:
Professional
All Job Posting Locations:
Gurabo, Puerto Rico, United States of America
Job Description:
We are searching for the best talent for a Sr. Manufacturing Process Owner to join our Team! This is an onsite/hybrid role.
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:
Preferred 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
The anticipated base pay range for this position is :
$77,000.00 - $123,050.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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
