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Senior Project Engineer-8135130513
Description
Ortho Biologics LLC, a member of Johnson & Johnson's Family of Companies located in Manatí, Puerto Rico, is recruiting a Senior Project Engineer.
Responsible for identifying, defining, design and management of capital projects in the manufacturing areas based on process improvement and cost reduction strategies; and business excellence projects to improve the performance and compliance of the equipments and/or new technologies. Responsible of identifying, design and propose new projects for process improvement in manufacturing areas, establishes user requirements, prepare business cases and financial analyses, to adopt or improve equipments. Responsible for Capital Budget Administration including the assistance to all departments in their appropriations and change control preparation. Assist in the development of Capital Budget, revisions, project concepts, proposals and strategic goals. Prepare project charters, Capital Appropriation Requests (CARs), and issue purchase orders. Recommend cost reduction opportunities. Lead project proposals through the Project Portfolio Management Team (PPMT). Manage the execution of assigned projects, meetings, resources, and budget requirements. Assure project completion by coaching operational teams, transferring documentation, standard operating procedures (SOP), technical aids, and spare parts inventory. Issue and manage Change Requests (CRs) for equipment modifications. Assure equipment is properly commissioned or qualified. Participate and serve as consultant in the troubleshooting and root cause analysis process for manufacturing equipment failures. Assist Production Maintenance Teams in the design of equipment improvements. Participate and advice operation teams in the Kaizen process for continuous improvement, reliability and performance of equipment. Maintain communication with the manufacturing area to assist in issues according to business priorities. Perform and/or provide assistance for investigations related to manufacturing equipment failures. Execute corrective and preventative actions (CAPAs) and audits resulting from equipment failures and deviations. Performs statistical and financial analysis on data. Assists in business excellence projects development and implementation. Responsible of identifying and contacting vendors and generating requisitions for engineering services and execution of non-capital projects. Works with Technical Service's group in order to provide them with all engineering related documentation and provides technical assistance in equipment validation. And perform control systems modifications, if necessary, to conduct validations. Revises drawings and provides technical information to the draftsperson, as required. Responsible of presenting active projects to internal and external Janssen SC management, when required. Actively participates in the review and completion of assigned Manufacturing Actions Plans (MAP). Assist in completion of non conformance and Manufacturing Action Plans commitments and corrective actions related to project, process and automation engineering. Participates in projects, programs and special activities that the company promotes geared toward establishing its strategic goals. Represents Engineering and Maintenance Department in the Safety and Environmental committees (ISO 14001 Team member). Responsible of reporting, maintaining, tracking and achieving plant goals in safety and environmental metrics for the engineering department. Perform safety audits, and track the implementation of recommendations. Also, submits the required documentation in a timely manner to safety and environmental department representative, if required. Observes all company policies, procedures, programs, systems, rules and regulations at all times of all compliance areas including but not limited to Safety, Environmental, Quality systems, Records Management, Human Resources, Security, GMP Manufacturing and others; and encourage co-workers to do so. Notifies any violation or deviation to his/her immediate supervisor or compliance area officer. Follows all guidelines established in the organization for the continuous improvement of the ISO 14001 system. Actively participates in the review of Environmental and Safety Management Actions Plans (sMAP). Attends applicable education and training programs and immediately informs supervisor if there are tasks or duties for which he/she is not properly trained. Serves as backup of the Engineering Manager. Performs any other duty assigned by supervisor.
Qualifications
A minimum of a Bachelor's degree in Electrical or Mechanical Engineering will be required. At least seven (7) years of experience in pharmaceutical environment is required. Experience working with the maintenance of manufacturing areas will be preferred. Registered Professional Engineer (PE) License to practice in Puerto Rico (in good standing), and active member of "Colegio de Ingenieros y Agrimensores de Puerto Rico" will be required. Black Belt or Green Belt Certification is preferred. Project Management Professional (PMP) Certification is preferred. Previous experience in project engineering and ability to read shop drawings will be required. Previous experience and knowledge in computer-aided design software (AutoCAD) will be required. Strong knowledge in programming and troubleshooting of programmable logic controllers (PLC) will be required. Experience working with electronic controlled equipment (such as vision systems, Optical Character Recognition, sensors, among others) will be required. Candidate must be proficient in the use of programs such as MS Office (Outlook, Excel, Word, and PowerPoint). Fully Bilingual (fluent English and Spanish, oral and written) is required. Availability to travel frequently inside and outside Puerto Rico (25%) is required. The selected candidate must be able to work on regular shifts, overtime and occasionally works on weekends. Physical requirements of the position includes: carries less than 10 pounds of force occasionally, constantly talking, and to see up close 20 inches or less, write, use keyboard with both hands and use of computer mouse, frequently sitting, twisting at waist and neck, stand, walk, climb ladders and stairs, bend, twist the hand and arm, perceive color, listen, vision 20 inches far away, peripheral vision, depth perception, reach above the elbow, and grab with both hands and entrance to hot and cold areas as well as confined spaces. Also could be exposed to changing climates, exposed to electrical panels, work in confined spaces, exposed to chemicals, biological agents, chemicals with acid base, and noise.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies!
Primary Location:North America-United States-Puerto Rico-Manatí
Organization: Ortho Biologics LLC (2164)
Relocation: Eligible
No
Travel:Yes, 25% of the time
Job Function: Process Engineering
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.
Senior Project Engineer-8135130513
Description
Ortho Biologics LLC, a member of Johnson & Johnson's Family of Companies located in Manatí, Puerto Rico, is recruiting a Senior Project Engineer.
Responsible for identifying, defining, design and management of capital projects in the manufacturing areas based on process improvement and cost reduction strategies; and business excellence projects to improve the performance and compliance of the equipments and/or new technologies. Responsible of identifying, design and propose new projects for process improvement in manufacturing areas, establishes user requirements, prepare business cases and financial analyses, to adopt or improve equipments. Responsible for Capital Budget Administration including the assistance to all departments in their appropriations and change control preparation. Assist in the development of Capital Budget, revisions, project concepts, proposals and strategic goals. Prepare project charters, Capital Appropriation Requests (CARs), and issue purchase orders. Recommend cost reduction opportunities. Lead project proposals through the Project Portfolio Management Team (PPMT). Manage the execution of assigned projects, meetings, resources, and budget requirements. Assure project completion by coaching operational teams, transferring documentation, standard operating procedures (SOP), technical aids, and spare parts inventory. Issue and manage Change Requests (CRs) for equipment modifications. Assure equipment is properly commissioned or qualified. Participate and serve as consultant in the troubleshooting and root cause analysis process for manufacturing equipment failures. Assist Production Maintenance Teams in the design of equipment improvements. Participate and advice operation teams in the Kaizen process for continuous improvement, reliability and performance of equipment. Maintain communication with the manufacturing area to assist in issues according to business priorities. Perform and/or provide assistance for investigations related to manufacturing equipment failures. Execute corrective and preventative actions (CAPAs) and audits resulting from equipment failures and deviations. Performs statistical and financial analysis on data. Assists in business excellence projects development and implementation. Responsible of identifying and contacting vendors and generating requisitions for engineering services and execution of non-capital projects. Works with Technical Service's group in order to provide them with all engineering related documentation and provides technical assistance in equipment validation. And perform control systems modifications, if necessary, to conduct validations. Revises drawings and provides technical information to the draftsperson, as required. Responsible of presenting active projects to internal and external Janssen SC management, when required. Actively participates in the review and completion of assigned Manufacturing Actions Plans (MAP). Assist in completion of non conformance and Manufacturing Action Plans commitments and corrective actions related to project, process and automation engineering. Participates in projects, programs and special activities that the company promotes geared toward establishing its strategic goals. Represents Engineering and Maintenance Department in the Safety and Environmental committees (ISO 14001 Team member). Responsible of reporting, maintaining, tracking and achieving plant goals in safety and environmental metrics for the engineering department. Perform safety audits, and track the implementation of recommendations. Also, submits the required documentation in a timely manner to safety and environmental department representative, if required. Observes all company policies, procedures, programs, systems, rules and regulations at all times of all compliance areas including but not limited to Safety, Environmental, Quality systems, Records Management, Human Resources, Security, GMP Manufacturing and others; and encourage co-workers to do so. Notifies any violation or deviation to his/her immediate supervisor or compliance area officer. Follows all guidelines established in the organization for the continuous improvement of the ISO 14001 system. Actively participates in the review of Environmental and Safety Management Actions Plans (sMAP). Attends applicable education and training programs and immediately informs supervisor if there are tasks or duties for which he/she is not properly trained. Serves as backup of the Engineering Manager. Performs any other duty assigned by supervisor.
Qualifications
A minimum of a Bachelor's degree in Electrical or Mechanical Engineering will be required. At least seven (7) years of experience in pharmaceutical environment is required. Experience working with the maintenance of manufacturing areas will be preferred. Registered Professional Engineer (PE) License to practice in Puerto Rico (in good standing), and active member of "Colegio de Ingenieros y Agrimensores de Puerto Rico" will be required. Black Belt or Green Belt Certification is preferred. Project Management Professional (PMP) Certification is preferred. Previous experience in project engineering and ability to read shop drawings will be required. Previous experience and knowledge in computer-aided design software (AutoCAD) will be required. Strong knowledge in programming and troubleshooting of programmable logic controllers (PLC) will be required. Experience working with electronic controlled equipment (such as vision systems, Optical Character Recognition, sensors, among others) will be required. Candidate must be proficient in the use of programs such as MS Office (Outlook, Excel, Word, and PowerPoint). Fully Bilingual (fluent English and Spanish, oral and written) is required. Availability to travel frequently inside and outside Puerto Rico (25%) is required. The selected candidate must be able to work on regular shifts, overtime and occasionally works on weekends. Physical requirements of the position includes: carries less than 10 pounds of force occasionally, constantly talking, and to see up close 20 inches or less, write, use keyboard with both hands and use of computer mouse, frequently sitting, twisting at waist and neck, stand, walk, climb ladders and stairs, bend, twist the hand and arm, perceive color, listen, vision 20 inches far away, peripheral vision, depth perception, reach above the elbow, and grab with both hands and entrance to hot and cold areas as well as confined spaces. Also could be exposed to changing climates, exposed to electrical panels, work in confined spaces, exposed to chemicals, biological agents, chemicals with acid base, and noise.
BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies!
Primary Location:North America-United States-Puerto Rico-Manatí
Organization: Ortho Biologics LLC (2164)
Relocation: Eligible
No
Travel:Yes, 25% of the time
Job Function: Process Engineering
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.