Operations Readiness Systems Manager-Oral Solid Dosage-00000Q3R
Description
This position is responsible for ensuring that the goals for the start-up scale-up of each systems at the China Xi’an New Manufacturing Site are identified, measured and accomplished in compliance and on time with the project schedule and within the defined budget. These 4 positions will be responsible for managing the schedules in each area, identify & mitigate schedule delays, responsible for construction quality of each system, facilities IQ, equipment IQ and commissioning, final take-over of each system from project to owners, and system qualification leading to a successful tech transfer and commercial operation.
This position will work with cross functional teams and partner with construction team, Manufacturing, QA, Engineering, Planning, Technology transfer in executing his/her duties, and to make sure that people and material resource are planned and solicited in line with the project schedule for plant operation scale-up.
This position is responsible and accountable for the prioritization and definition of technical projects impacting compliance, customer service and cost for the start-up and scale-up phases. Encourages and supports the identification and development of innovative solutions to problems and opportunities. Provides technical support and knowledge to Operations, Engineering and QA during quality investigations and Compliance Audits.
Ensure quality and compliance in all my actions by:
o Attend GMP training on the schedule designated for my role and as appropriate for my role
o Adhere to strict compliance with procedures applicable to my role.
o Exercise the highest level of integrity in the tasks that I perform
o In a timely and prompt manner, identify & report and seek correction for deviations noted in my workplace.
o Embrace a behavior of employee involvement and commitment to doing the job right the first time
People
o Promote an environment of employee involvement in the workplace.
o Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.
Operations and Project Management
o Provide direction for the key projects as part of the start-up and scale up of each system.
o Ensure clear identification of project goals and the benefits to be realized.
o Provide guidance and support to resolve issues impacting timely completion and achievement of project goals and managing the capital and expenses budget associated to the projects for the start up and scale up phases.
o The position is responsible to develop, implement and maintain processes and systems to manage technical projects for the site management team impacting compliance, cost, and customer service (to include capacity improvements) and products introduction and launches for the start up and scale up.
o Leads periodic reviews of portfolio, business benefits realized, key performance indicators and gaps as part of the start-up and operations scale up projects.
o Provides source of information to the site management team for prioritization of projects and technical resources as needed
o Prepare and manage project operating budget and capital budgets
Qualifications
Experience:
Minimum of 5 years in respective area of expertise (Technical Services, Process Engineering, Manufacturing operations (OSD, Non-solid), Warehouse & Material handling) with 3+ years’ experience supporting Pharmaceutical Manufacturing sites. Knowledge, skills, and demonstrated results in project management, project prioritization, technology transfer process, and FDA audits and audit management would be an advantage.
Physical Demands:
Occasional travel might be needed about 10%-20% of the time
Knowledge, Skills and Abilities:
Demonstrate effective decision-making and problem-solving with direct experience in managing non-compliance, customer service and cost implications in past experience.
Fluent knowledge of Company, industry, and regulatory standards and data-based decision to include root cause analyses, cost/benefit, and risk assessment.
Decisions made and/or influenced by this position will have an immediate impact and a 1-2 year strategic direction for projects and resources.
Innovation and creativity are required to meet project objectives while adhering to compliance, safety, cGMP environment, cost, schedule, and other regulations and guidelines.
Interaction with site leadership team to assess performance and issues, exchange information, provide advice/recommendations on important matters, and influence/persuade on matters of significance.
Frequent interaction with internal R&D, QA, and Technical Operations leadership regarding new product development and commercialization, product/process capability issues, and policies/procedures.
Occasional interaction with government agencies regarding regulations, audits, filings, and corrective action plans.
Occasional interaction with external J&J customers regarding technical issues impacting product supply, new/modified products, product performance assessments, etc.
Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 10 % of the Time
Job Function: Engineering (Generalist)
Description
This position is responsible for ensuring that the goals for the start-up scale-up of each systems at the China Xi’an New Manufacturing Site are identified, measured and accomplished in compliance and on time with the project schedule and within the defined budget. These 4 positions will be responsible for managing the schedules in each area, identify & mitigate schedule delays, responsible for construction quality of each system, facilities IQ, equipment IQ and commissioning, final take-over of each system from project to owners, and system qualification leading to a successful tech transfer and commercial operation.
This position will work with cross functional teams and partner with construction team, Manufacturing, QA, Engineering, Planning, Technology transfer in executing his/her duties, and to make sure that people and material resource are planned and solicited in line with the project schedule for plant operation scale-up.
This position is responsible and accountable for the prioritization and definition of technical projects impacting compliance, customer service and cost for the start-up and scale-up phases. Encourages and supports the identification and development of innovative solutions to problems and opportunities. Provides technical support and knowledge to Operations, Engineering and QA during quality investigations and Compliance Audits.
Ensure quality and compliance in all my actions by:
o Attend GMP training on the schedule designated for my role and as appropriate for my role
o Adhere to strict compliance with procedures applicable to my role.
o Exercise the highest level of integrity in the tasks that I perform
o In a timely and prompt manner, identify & report and seek correction for deviations noted in my workplace.
o Embrace a behavior of employee involvement and commitment to doing the job right the first time
People
o Promote an environment of employee involvement in the workplace.
o Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.
Operations and Project Management
o Provide direction for the key projects as part of the start-up and scale up of each system.
o Ensure clear identification of project goals and the benefits to be realized.
o Provide guidance and support to resolve issues impacting timely completion and achievement of project goals and managing the capital and expenses budget associated to the projects for the start up and scale up phases.
o The position is responsible to develop, implement and maintain processes and systems to manage technical projects for the site management team impacting compliance, cost, and customer service (to include capacity improvements) and products introduction and launches for the start up and scale up.
o Leads periodic reviews of portfolio, business benefits realized, key performance indicators and gaps as part of the start-up and operations scale up projects.
o Provides source of information to the site management team for prioritization of projects and technical resources as needed
o Prepare and manage project operating budget and capital budgets
Qualifications
Experience:
Minimum of 5 years in respective area of expertise (Technical Services, Process Engineering, Manufacturing operations (OSD, Non-solid), Warehouse & Material handling) with 3+ years’ experience supporting Pharmaceutical Manufacturing sites. Knowledge, skills, and demonstrated results in project management, project prioritization, technology transfer process, and FDA audits and audit management would be an advantage.
Physical Demands:
Occasional travel might be needed about 10%-20% of the time
Knowledge, Skills and Abilities:
Demonstrate effective decision-making and problem-solving with direct experience in managing non-compliance, customer service and cost implications in past experience.
Fluent knowledge of Company, industry, and regulatory standards and data-based decision to include root cause analyses, cost/benefit, and risk assessment.
Decisions made and/or influenced by this position will have an immediate impact and a 1-2 year strategic direction for projects and resources.
Innovation and creativity are required to meet project objectives while adhering to compliance, safety, cGMP environment, cost, schedule, and other regulations and guidelines.
Interaction with site leadership team to assess performance and issues, exchange information, provide advice/recommendations on important matters, and influence/persuade on matters of significance.
Frequent interaction with internal R&D, QA, and Technical Operations leadership regarding new product development and commercialization, product/process capability issues, and policies/procedures.
Occasional interaction with government agencies regarding regulations, audits, filings, and corrective action plans.
Occasional interaction with external J&J customers regarding technical issues impacting product supply, new/modified products, product performance assessments, etc.
Primary Location:Asia Pacific-China-Shaanxi-Xi'an
Organization: Xian-Janssen Pharmaceutical Ltd. (7043)
Travel:Yes, 10 % of the Time
Job Function: Engineering (Generalist)