Johnson & Johnson companies are equal opportunity employers.
MANUFACTURING SYSTEMS TEAM LEAD-8883140415
Description
For more than 30 years, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. pursues innovative solutions in the therapeutic areas of immunology, oncology, urology and nephrology. With the same unwavering passion for new challenges, we dedicate ourselves to delivering solutions for these disease states where unmet needs continue to exist. Rooted in rich scientific collaborations and community-based relationships, we have access to some of the top minds in science today, allowing us to advance the treatment of patients through our innovative medicines. Our discoveries lead us not only to new treatments, but also to new ways to empower patients and expand their access to quality care.
The Manufacturing Systems Team Lead is responsible for providing leadership within the Manufacturing Systems Team to meet the safety, environmental, cost, quality, and production needs of the Malvern Manufacturing Site. Partners and collaborates with Manufacturing Cell/ COE Leaders to ensure that manufacturing systems are developed and maintained to continually meet the needs of the business in a cost-effective and timely manner. Accountable for fostering a positive work environment and a collaborative “can-do” culture.
Supervises the Automation Support staff and is accountable for the business results of the MES Managed Service. Provides leadership and direction to colleagues and direct reports within the Manufacturing Systems department. Develops and manages the support model for Manufacturing Systems and initiatives including but not limited to MES, DeltaV, SCADA, Osi PI, and the network infrastructure. Provides input to the design and implementation of Manufacturing Systems and initiatives including but not limited to MES, DeltaV, SCADA, Osi PI, and the network infrastructure. Develops guidelines for design, review and approval of master batch records (MBRs) and equipment specifications (ESPs), and MES master data. Ensures that Manufacturing Systems resources and activities are planned and executed to meet business needs and the manufacturing schedule. Accountable for updates to standard operating procedures (SOPs) within the Manufacturing System Department. Participate in development and execution of the Manufacturing Systems Strategy to align within current regulations, J&J, industry, as well as the Malvern Site Master Plan. Promote a culture of continuous improvement and open communication. Ensure that personnel are recruited, trained, and developed to support activities in line with business needs and site recruitment plan. Liaise closely with corporate partners, COEs and IT/Automation teams, to ensure implementation and ongoing operational effectiveness of manufacturing systems. Support investigation and resolution of process issues. Interact with production personnel to propose and assess modifications to equipment and processes to improve the safety and/or efficiency of plant operations. Ensure all systems or changes are developed and implemented in compliance with Company policies and procedures, FDA regulations, cGMPs, and are validated as necessary. Support internal and external audits as a subject matter expert within manufacturing systems. This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures. Successfully completes regulatory and job training requirements. Makes a positive contribution as demonstrated by: making suggestions for improvement and learning new skills, procedures and processes. Assures the Manufacturing Systems Department interfaces with other cells, COE’s and other J&J organizations in a positive, productive and professional manner. Remains current in skills and industry trends.
Qualifications
B.S. degree is required. Engineering (i.e. Mechanical, Electrical, or Chemical) or related area is preferred. A minimum of 5 years of experience in control system design and implementation is required. A minimum of 8 years of experience within a pharmaceutical or GMP related manufacturing environment or an equivalent combination of education and experience is required. Experience in supervision/management of people and resources are preferred. MES (Manufacturing Execution System) or similar system is preferred. Business and strategic acumen, including project management and financial management experience preferred. Demonstrated ability to lead technical resources, manages multiple customer needs, prioritize work and deliver results required. Influencing skills, partnering and collaboration skills, analytical skills and excellent oral and written presentation skills are required, with a demonstrated ability to work across organizational boundaries.
This position is located in Malvern, PA and may require up to 10% travel domestically and internationally.
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 NA
Primary Location:North America-United States-Pennsylvania-Malvern
Organization: Janssen Biotech, Inc. (6014)
Job Function: Engineering (Generalist)
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
MANUFACTURING SYSTEMS TEAM LEAD-8883140415
Description
For more than 30 years, Janssen Biotech, Inc. has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a rich legacy of innovative firsts, Janssen Biotech, Inc. pursues innovative solutions in the therapeutic areas of immunology, oncology, urology and nephrology. With the same unwavering passion for new challenges, we dedicate ourselves to delivering solutions for these disease states where unmet needs continue to exist. Rooted in rich scientific collaborations and community-based relationships, we have access to some of the top minds in science today, allowing us to advance the treatment of patients through our innovative medicines. Our discoveries lead us not only to new treatments, but also to new ways to empower patients and expand their access to quality care.
The Manufacturing Systems Team Lead is responsible for providing leadership within the Manufacturing Systems Team to meet the safety, environmental, cost, quality, and production needs of the Malvern Manufacturing Site. Partners and collaborates with Manufacturing Cell/ COE Leaders to ensure that manufacturing systems are developed and maintained to continually meet the needs of the business in a cost-effective and timely manner. Accountable for fostering a positive work environment and a collaborative “can-do” culture.
Supervises the Automation Support staff and is accountable for the business results of the MES Managed Service. Provides leadership and direction to colleagues and direct reports within the Manufacturing Systems department. Develops and manages the support model for Manufacturing Systems and initiatives including but not limited to MES, DeltaV, SCADA, Osi PI, and the network infrastructure. Provides input to the design and implementation of Manufacturing Systems and initiatives including but not limited to MES, DeltaV, SCADA, Osi PI, and the network infrastructure. Develops guidelines for design, review and approval of master batch records (MBRs) and equipment specifications (ESPs), and MES master data. Ensures that Manufacturing Systems resources and activities are planned and executed to meet business needs and the manufacturing schedule. Accountable for updates to standard operating procedures (SOPs) within the Manufacturing System Department. Participate in development and execution of the Manufacturing Systems Strategy to align within current regulations, J&J, industry, as well as the Malvern Site Master Plan. Promote a culture of continuous improvement and open communication. Ensure that personnel are recruited, trained, and developed to support activities in line with business needs and site recruitment plan. Liaise closely with corporate partners, COEs and IT/Automation teams, to ensure implementation and ongoing operational effectiveness of manufacturing systems. Support investigation and resolution of process issues. Interact with production personnel to propose and assess modifications to equipment and processes to improve the safety and/or efficiency of plant operations. Ensure all systems or changes are developed and implemented in compliance with Company policies and procedures, FDA regulations, cGMPs, and are validated as necessary. Support internal and external audits as a subject matter expert within manufacturing systems. This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned. Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, and OSHA. Complies with all company and site policies and procedures. Successfully completes regulatory and job training requirements. Makes a positive contribution as demonstrated by: making suggestions for improvement and learning new skills, procedures and processes. Assures the Manufacturing Systems Department interfaces with other cells, COE’s and other J&J organizations in a positive, productive and professional manner. Remains current in skills and industry trends.
Qualifications
B.S. degree is required. Engineering (i.e. Mechanical, Electrical, or Chemical) or related area is preferred. A minimum of 5 years of experience in control system design and implementation is required. A minimum of 8 years of experience within a pharmaceutical or GMP related manufacturing environment or an equivalent combination of education and experience is required. Experience in supervision/management of people and resources are preferred. MES (Manufacturing Execution System) or similar system is preferred. Business and strategic acumen, including project management and financial management experience preferred. Demonstrated ability to lead technical resources, manages multiple customer needs, prioritize work and deliver results required. Influencing skills, partnering and collaboration skills, analytical skills and excellent oral and written presentation skills are required, with a demonstrated ability to work across organizational boundaries.
This position is located in Malvern, PA and may require up to 10% travel domestically and internationally.
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 NA
Primary Location:North America-United States-Pennsylvania-Malvern
Organization: Janssen Biotech, Inc. (6014)
Job Function: Engineering (Generalist)
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.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement