Mfg Technical Specialist III-Purification
Roche - Oceanside, CA

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Responsible for executing technical support activities for GMP Purification Manufacturing Operations in a multi product, large scale, automated biopharmaceutical facility. This includes activities related to safety, compliance, quality, staff development, targeted innovation, and plant performance and success. Deliverables include but are not limited to leading or executing implementation of targeted new technologies and procedures, assessing, evaluating and providing immediate corrective actions for GMP discrepancies and intra batch process monitoring, analysis and reporting. First line of defense for all manufacturing excursions, GMP lifecycle management of execution level process data, providing for unit operation process monitoring and data mining as well as SME level assessment of changes and improvements

Job Responsibilities

Essential

Proven ability to provide on-call technical support for a 24/7 purification manufacturing operation. This includes being available to respond to requests for assistance from the Manufacturing floor related to automation, equipment or process issues.

Provide technical input for generation and change assessment to quality controlled documentation including SOP's, Work Instructions, Data Forms, MES/DCS operator prompts, etc.

Provides the requisite regulatory and process knowledge required to translate high-level quality requirements into compliant and effective process documentation and guidance

Provide technical support for all associated Make-Assess-Release activities, including monitoring, trouble-shooting, corrective action and assessment and remediation of discrepant incidents impacting manufacturing materials, methods and equipment.

Manage the lifecycle of execution level process data and specifications.

Partners with support functions to drive implementation of manufacturing continuous improvement initiatives and support of New Product Introduction (NPI).

Serve as Risk Assessment Lead to support risk analysis activities aimed at providing the most compliant and robust execution of production at a unit operation level.

Facilitate purification batch monitoring through evaluation of targeted production outputs of both routine (trend review, Batch Record information) and atypical nature (e.g. Discrepancies, Out Of Specification) and by providing data analysis, trend reviews and summary data to that activity as part of ongoing plant operations.

All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).

Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area. Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities

Guides campaign based and detailed material requirements and changes to site logistics and planning functions. Ensures correct inputs for material planning models and maintains execution level data to define process and material requirements, targeted safety stock levels and provides solutions to material availability issues.

Provides directed and specific training content and curriculum for execution level knowledge of process and equipment fit, form and function as they relate to unit operation execution concepts and principles in our specific plant.

May provide support for non-routine Maintenance activities.

Fosters open communication, teamwork and transparency by aligning efforts and knowledge sharing.

Serve as Corrective Action and Preventative Action Owner and Assignee to address issues of process, equipment, automation or methods that directly impact production.

Demonstrated working knowledge of process control, manufacturing execution and enterprise resource planning systems.

May lead or serve on cross-functional/global teams in regards to business processes and sharing best practices with the site.

May provide leadership in safety, quality, compliance, efficiency, and continuous improvement efforts.
Bachelor's, Master's, or Ph.D. degree in Engineering or Life Sciences.

Experience with purification processes is highly desirable.

6-8 years experience in related field.

4-6 years with Master

1-3 years with Ph.D.

Knowledge, Skills, and Abilities

Proven knowledge and practical experience with core regulatory requirements

Demonstrated ability to create and maintain compliant systems and behaviors, interact in an inspection context, analyze and interpret regulatory trends and present and defend to global regulatory bodies.

Demonstrated working knowledge of process control, manufacturing execution and enterprise resource planning systems.

Proven management, communication, interpersonal, organizational and project management skills.

Demonstrated ability to work as part of a multi-disciplinary team.

Proven ability to work with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines.

Demonstrated proficiency in the application of basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharmaceutical manufacturing processes.

Ability to interact within and across work groups and with outside collaborators and vendors on technical matters.

Demonstrated technical proficiency, leadership, creativity, and strategic thinking.

Practical and theoretical expertise in biopharmaceutical manufacturing processes engineering and applied technologies.

Strong oral and written communication skills.

Work Environment/Physical Demands/Safety Considerations

Work in office and, to a lesser extent, laboratory environment.

May be on feet for 4 to 5 hours a day.

Lifting up to 25lbs may be required.

May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn. Also, no make up or jewelry can be worn when working in the clean room environment.

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Roche is on a medicinal roll. The company operates two segments, pharmaceuticals and diagnostics, and sells its products in some 180...