Johnson & Johnson companies are equal opportunity employers.
Master Batch Record / Master Data Designer 2-4496131125
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Master Batch Record (MBR) / Master Data (MD) Designer 2, for the facility located in Las Piedras, Puerto Rico.
McNeil Consumer Healthcare Division of McNeil -PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, MOTRIN® IB, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J family of companies or beyond, or whether this is your entry to the J&J family of companies, we invite you to join us?. Creating the future of McNeil.
The Master Batch Record (MBR) / Master Data (MD) Designer 2 will provide system and processes technical knowledge, expertise and hands-on experience in the design, creation, modification, configuration and implementation of Electronic Master Batch Records, including the design, creation and modification of Master Data in the ELECTRONIC System, for the Manufacturing operations of McNeil Healthcare LLC in Las Piedras, PR. In addition, it will provide technical knowledge and expertise in systems and processes to the MBR Department in assessing the cross-functional impact of MBRs proposed changes, including process improvement initiatives through the direct and indirect organization in formal and informal roles. Drives continuous improvement processes and opportunities. Must have deep technical knowledge, expertise and hands-on experience in System Development Life Cycle (SDLC), Computer Systems Validation (CSV) and Process Validation including Technology, Products and Manufacturing Processes Transfer. Attends GMP trainings on the schedule designated for the role and as appropriate for the role. Adheres to strict compliance with procedures applicable to the role. Exercises the highest level of integrity in the tasks performed. In a timely and prompt manner, identifies, reports and seeks correction for deviations noted in the workplace. Embraces a behavior of employee involvement and commitment to doing the job right the first time. Promotes an environment of employee involvement in the workplace. Seeks prompt identification, reporting and correction of deviations in the workplace as noted by employees. Acts in accordance to the principles expressed in Our Credo and the Quality Statement in all negotiations and activities within and outside the company, and assures these are met. Assures trainings in the assigned tasks have been delivered prior to execution. Leads the Maintenance of information such as instructions, steps material data, equipment and process in the Electronic Master Batch Records (MBRs) in the ELECTRONIC System. Leads the Maintenance of Master Data such as equipment, material data, compatibility rules, locations, production units, state diagrams, and Electronic Batch Records (EBR) approval roles, among others to support the ELECTRONIC system for business areas. Leads the development, oversees and / or delivers training for SOP and Master Batch Records related to the Electronic batch record process. Leads the development and re-engineering of manufacturing / packaging batch records in order to create the new Electronic batch records in the ELECTRONIC System. Assure all manufacturing processes in the MBR are aligned with the validated state. Assures the accurate and timely transfer and approval process of the manufacturing and / or packaging MBR to the ELECTRONIC System. Review and approve the manufacturing and packaging procedures in alignment with the ELECTRONIC System. Ensures that the goals and objectives established in action plans and projects are aligned with the goals and overall business objectives. Supports the development of business objectives, as required. Gathers data to develop and present metrics related to projects. Leads continuous improvement processes and projects. Serves as an internal cross functional expert and representative for the site and on McNeil supply chain teams, maintaining close alignment with others ELECTRONIC implementations. Able to show results against execution and coordination of ongoing process improvement plans through metrics and achievement of milestones. Communicates progress to site management and others, as required. Analyze and prioritize overall site support requests related to MBR. Drives improvements and results through influence with site and across McNeil supply chain teams. Asses and manage cross-functional impacts of MBR's changes proposed by others. Coordinates an effective support process that drives timely resolution of MBR support for manufacturing and packaging areas. Attends and complies with applicable education and training programs and proactively identifies new trainings or certifications to ensure right level of business support. Participates in special activities that the company promotes geared toward establishing its strategic goals. Complies with the company policies, procedures and rules, as well as with those of regulatory agencies and ensures compliance of such. Performs any other duty related to the position assigned by the supervisor. All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
The position requires Bachelor and/or Master in Science, Technology, or Engineering. A minimum of four (4) years of experience working in a GMP product manufacturing plant environment is required. A minimum of three (3) years of hands-on experience, expertise and deep technical knowledge in System Development Life Cycle (SDLC), Computer Systems Validation (CSV) and Process Validation including Technology, Products and Manufacturing Processes Transfer. At least two (2) years of hands-on expertise in experience and knowledge the design, creation, modification and configuration of Electronic Master Batch Records using ELECTRONIC System including leading master data creation and configuration for the ELECTRONIC System is required. Broad working knowledge of the pharmaceutical drug product operating functions of quality and compliance, material supply, material handling and control, product manufacturing, and product packaging is required. The position requires sedentary work that requires minimum physical effort. Also requires communication skills, eye-hand coordination, and the ability to move. Near and far visual discrimination, depth perception, depth of color, heat depth, visual field, visual and color accommodation. Must be bilingual (English and Spanish). Strong working knowledge in statistics, GMP and pharmaceutical industry applicable regulations is required. Proficiency in Microsoft Office applications (Outlook, Word, Excel, and PowerPoint) is required. Ability to advise, calculate, categorize, classify, compare, coordinate, detect, diagnose, edit, estimate, evaluate, interview, influence, inspect, instruct, interpret, read, negotiate, observe, organize, plan, gather information, recruit, supervise, select, analyze and document. Ability to establish positive interpersonal relationships and interact with people effectively, work under a lot of time pressure and make decisions accordingly will be required. Must be able to take initiative and make good judgment in the performance of duties. The position may require traveling in and outside of Puerto Rico. Also requires to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business. Must be able to support other departments or projects according to business needs.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI
Primary Location:North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Relocation: Eligible No
Travel:Yes, 25 % of the Time
Job Function: Quality Control
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Master Batch Record / Master Data Designer 2-4496131125
Description
McNeil Healthcare LLC, a member of Johnson & Johnson's Family of Companies, is recruiting a Master Batch Record (MBR) / Master Data (MD) Designer 2, for the facility located in Las Piedras, Puerto Rico.
McNeil Consumer Healthcare Division of McNeil -PPC, Inc markets a broad range of over-the-counter products, including TYLENOL® acetaminophen products, ZYRTEC® and BENADRYL® allergy medicines, MOTRIN® IB, ROLAIDS® antacid products, ST. JOSEPH® Adult Regimen Aspirin, and SUDAFED® nasal decongestants. McNeil-PPC, Inc. entered into a consent decree, or agreement, with the agency that governs certain manufacturing operations to help ensure quality and compliance. Now is an exciting time to join our business, as we focus on reaffirming the integrity of our iconic brands that are staples of households worldwide. Whether you view this opportunity as a potential career accelerator here, within the J&J family of companies or beyond, or whether this is your entry to the J&J family of companies, we invite you to join us?. Creating the future of McNeil.
The Master Batch Record (MBR) / Master Data (MD) Designer 2 will provide system and processes technical knowledge, expertise and hands-on experience in the design, creation, modification, configuration and implementation of Electronic Master Batch Records, including the design, creation and modification of Master Data in the ELECTRONIC System, for the Manufacturing operations of McNeil Healthcare LLC in Las Piedras, PR. In addition, it will provide technical knowledge and expertise in systems and processes to the MBR Department in assessing the cross-functional impact of MBRs proposed changes, including process improvement initiatives through the direct and indirect organization in formal and informal roles. Drives continuous improvement processes and opportunities. Must have deep technical knowledge, expertise and hands-on experience in System Development Life Cycle (SDLC), Computer Systems Validation (CSV) and Process Validation including Technology, Products and Manufacturing Processes Transfer. Attends GMP trainings on the schedule designated for the role and as appropriate for the role. Adheres to strict compliance with procedures applicable to the role. Exercises the highest level of integrity in the tasks performed. In a timely and prompt manner, identifies, reports and seeks correction for deviations noted in the workplace. Embraces a behavior of employee involvement and commitment to doing the job right the first time. Promotes an environment of employee involvement in the workplace. Seeks prompt identification, reporting and correction of deviations in the workplace as noted by employees. Acts in accordance to the principles expressed in Our Credo and the Quality Statement in all negotiations and activities within and outside the company, and assures these are met. Assures trainings in the assigned tasks have been delivered prior to execution. Leads the Maintenance of information such as instructions, steps material data, equipment and process in the Electronic Master Batch Records (MBRs) in the ELECTRONIC System. Leads the Maintenance of Master Data such as equipment, material data, compatibility rules, locations, production units, state diagrams, and Electronic Batch Records (EBR) approval roles, among others to support the ELECTRONIC system for business areas. Leads the development, oversees and / or delivers training for SOP and Master Batch Records related to the Electronic batch record process. Leads the development and re-engineering of manufacturing / packaging batch records in order to create the new Electronic batch records in the ELECTRONIC System. Assure all manufacturing processes in the MBR are aligned with the validated state. Assures the accurate and timely transfer and approval process of the manufacturing and / or packaging MBR to the ELECTRONIC System. Review and approve the manufacturing and packaging procedures in alignment with the ELECTRONIC System. Ensures that the goals and objectives established in action plans and projects are aligned with the goals and overall business objectives. Supports the development of business objectives, as required. Gathers data to develop and present metrics related to projects. Leads continuous improvement processes and projects. Serves as an internal cross functional expert and representative for the site and on McNeil supply chain teams, maintaining close alignment with others ELECTRONIC implementations. Able to show results against execution and coordination of ongoing process improvement plans through metrics and achievement of milestones. Communicates progress to site management and others, as required. Analyze and prioritize overall site support requests related to MBR. Drives improvements and results through influence with site and across McNeil supply chain teams. Asses and manage cross-functional impacts of MBR's changes proposed by others. Coordinates an effective support process that drives timely resolution of MBR support for manufacturing and packaging areas. Attends and complies with applicable education and training programs and proactively identifies new trainings or certifications to ensure right level of business support. Participates in special activities that the company promotes geared toward establishing its strategic goals. Complies with the company policies, procedures and rules, as well as with those of regulatory agencies and ensures compliance of such. Performs any other duty related to the position assigned by the supervisor. All McNeil employees are required to cultivate an environment of quality & compliance in their actions. This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create & maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
The position requires Bachelor and/or Master in Science, Technology, or Engineering. A minimum of four (4) years of experience working in a GMP product manufacturing plant environment is required. A minimum of three (3) years of hands-on experience, expertise and deep technical knowledge in System Development Life Cycle (SDLC), Computer Systems Validation (CSV) and Process Validation including Technology, Products and Manufacturing Processes Transfer. At least two (2) years of hands-on expertise in experience and knowledge the design, creation, modification and configuration of Electronic Master Batch Records using ELECTRONIC System including leading master data creation and configuration for the ELECTRONIC System is required. Broad working knowledge of the pharmaceutical drug product operating functions of quality and compliance, material supply, material handling and control, product manufacturing, and product packaging is required. The position requires sedentary work that requires minimum physical effort. Also requires communication skills, eye-hand coordination, and the ability to move. Near and far visual discrimination, depth perception, depth of color, heat depth, visual field, visual and color accommodation. Must be bilingual (English and Spanish). Strong working knowledge in statistics, GMP and pharmaceutical industry applicable regulations is required. Proficiency in Microsoft Office applications (Outlook, Word, Excel, and PowerPoint) is required. Ability to advise, calculate, categorize, classify, compare, coordinate, detect, diagnose, edit, estimate, evaluate, interview, influence, inspect, instruct, interpret, read, negotiate, observe, organize, plan, gather information, recruit, supervise, select, analyze and document. Ability to establish positive interpersonal relationships and interact with people effectively, work under a lot of time pressure and make decisions accordingly will be required. Must be able to take initiative and make good judgment in the performance of duties. The position may require traveling in and outside of Puerto Rico. Also requires to work extra hours and to respond to emergency calls that require returning to the company after regular working hours of the business. Must be able to support other departments or projects according to business needs.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies
J2W:LI
Primary Location:North America-United States-Puerto Rico-Las Piedras
Organization: McNeil Healthcare LLC (7598)
Relocation: Eligible No
Travel:Yes, 25 % of the Time
Job Function: Quality Control
Certain sites within the Johnson & Johnson family of companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.