Specialist Mfg Execution Systems (31892) – Juncos, PR

Requirements Education / Years of Experience
Doctorate degree OR Master’s degree & 3 years of manufacturing industry experience OR
Bachelor’s degree & 5 years of manufacturing industry experience OR Associate’s degree and 10 years of manufacturing industry experience OR High School Diploma/GED and 12 years of manufacturing industry experience

Preferred Qualifications
• Support non-standard shift organization, including weekends and extended hours as per business needs.
• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Manufacturing Execution System (MES)
• Configuration of Master Batch Records (MBR), Generic Master Batch Record (GMBR), Parameter Value List (PVL)
• Configuration of Equipment Management (EQM) including state diagrams and the integration with the MBR/GMBR
• Configuration of Characteristics Values (CX) for data transfer
• Configuration of Level 2 integration (MES connectivity to Control Systems and stand-alone equipment)
• Use of Application Life Cycle Management (ALM) system to document designs validation
• Provide troubleshooting support to MES users
• Training delivery to MES users

Systems Applications and Products (SAP) system
• Navigation through common transactions (master data, process orders release, production versions, inventory availability, bill of materials, etc.)
• Understand the connectivity between SAP and MES to be able to troubleshoot when the communication among the systems is not as expected (idoc’s management)
• Detailed technical understanding of bioprocessing unit operations

 

Process Monitoring
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation
• Assist with generation of process validation protocols and reports.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.

Regulatory
• May participate in regulatory inspections

New Product Introductions (NPI) & Process or Equipment Modifications
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control
• Assist manufacturing change owner on CCRB packages impacting the process.

Projects and Initiatives
• Participate on the assessment or implementation of special projects or initiatives.

Description:

Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

SUMMARY
With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. This role is crucial for client’s success and it will be a key contributor in the manufacturing area within the administrative shift as a standard schedule.

SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:
Applied Process and Systems Expertise
• Support non-standard shift organization, including weekends and extended hours as per business needs.
• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Provide troubleshooting support.
• Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.

Manufacturing Execution System (MES)
o Configuration of Master Batch Records (MBR), Generic Master Batch Record (GMBR), Parameter Value List (PVL)
o Configuration of Equipment Management (EQM) including state diagrams and the integration with the MBR/GMBR
o Configuration of Characteristics Values (CX) for data transfer
o Configuration of Level 2 integration (MES connectivity to Control Systems and stand-alone equipment)
o Use of Application Life Cycle Management (ALM) system to document designs validation
o Provide troubleshooting support to MES users
o Training delivery to MES users

Systems Applications and Products (SAP) system
o Navigation through common transactions (master data, process orders release, production versions, inventory availability, bill of materials, etc.)
o Understand the connectivity between SAP and MES to be able to troubleshoot when the communication among the systems is not as expected (idoc’s management)

• Detailed technical understanding of bioprocessing unit operations

Process Monitoring
• Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations.
• Provide support of timely execution of the process monitoring quarterly reports.

Non-Conformance and CAPA
• Ensure that all Non-conformances are triaged within the established goal.
• Responsible for authoring investigation reports.
• Responsible for execution of corrective actions.
• Responsible for managing NC/CAPA closure within established goal.
• Monitor and communicate incidents trends.
• Review equipment/system Root Cause Analysis investigations and support trend evaluations.

Process Validation
• Assist with generation of process validation protocols and reports.
• Assist with the execution of the process validation.
• Support collection and analysis of process validation data.
Regulatory
• May participate in regulatory inspections
New Product Introductions (NPI) & Process or Equipment Modifications
• Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
• Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.

Change Control
• Assist manufacturing change owner on CCRB packages impacting the process.
Projects and Initiatives
• Participate on the assessment or implementation of special projects or initiatives.

EDUCATION/LICENSES
Doctorate degree OR Master’s degree & 3 years of manufacturing industry experience OR
Bachelor’s degree & 5 years of manufacturing industry experience OR Associate’s degree and 10 years of manufacturing industry experience OR High School Diploma/GED and 12 years of manufacturing industry experience

PREFERRED QUALIFICATIONS

• Education discipline in Life Science, Computer Science and/or Engineering
• Proficient on Manufacturing Execution System (MES) and/or Systems Applications and Products (SAP) system
• Detailed technical understanding of bioprocessing unit operations
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
• Organizational, technical writing and presentation skills.
• Project management skills
• Knowledge of control charting
• Availability to support non-standard shift
• Experience in Root Cause Analysis (Fishbone, 5 Why’s, Kepner Tregoe)
• Excellent communication skills in English and Spanish

Client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, client has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Client is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Administrative Shift