Manufacturing Process Technologist

POSITION SUMMARY

In the assigned manufacturing area, directly supports the Vivitrol Manufacturing Process. Actively supports ongoing manufacturing efforts in terms of quality and efficiency, provides an interface with Development and Engineering in technology transfer of new processes and process upgrades to existing technologies, and supports Corrective and Preventive Action programs. Conducts real-time monitoring/trending of manufacturing processes and finished product analytical data.

 

MAJOR RESPONSIBILITIES

• Develops and maintains databases that provide trending capability for process parameters.
• Develops and maintains (tracks) Aristada production metrics using analytical tools.
• Conducts frequent and thorough periodic reviews of the database and trends, identifying opportunities for improvement in performance in process, manpower effectiveness, and efficiency.
• Actively identifies unfavorable trends and investigates root cause as well as effective preventive actions.
• Provides leadership and manufacturing support in investigations, as assigned.
• Assures the resolution of deviations, corrective actions, Change Control action items, and any audit non-compliance items.
• Ensures the timely completion of assigned deviations and CAPAs
• Performs process and equipment evaluation (FMEA, etc) to identify risks and weaknesses in new and current processes.
• Writes/revises, develops, and implements SOPs and other GMP documentation in support of new or changed manufacturing processes in cooperation with appropriate manufacturing personnel.
• Establishes familiarity with all manufacturing activities involved in the sterile production process to share best practices and streamline operations.
• Develops and implements effective training of manufacturing personnel related to technical transfer and process upgrades.
• Acts as a manufacturing liaison in project planning and coordination.
• Represents manufacturing on process design teams.
• Champions projects as they move into and through the manufacturing areas.
• Authors, drives, and assures accurate and timely execution of process Change Controls; Partners with other bulk groups when necessary.
• Provide regular updates to manufacturing management on the status and issues involved in projects.
• Performs troubleshooting of issues and non-conformance items
• Provides administrative support to manufacturing in authoring and reviewing engineering/validation documentation, as assigned.
• Supports manufacturing management in periodic review of existing and new revisions to manufacturing documentation in regard to (but not limited to) Operability, Technical accuracy, Compliance, and Process Robustness.
• Supports production of pharmaceutical formulations.
• Maintains individual training proficiency; Trains operators on processes.
• Documents all work as required by cGMPs on a timely basis.
• Abides by all safety requirements as defined by the company.
• Assists with RCRA and safety inspections, as required.
• Other tasks as assigned by management.t
• Working conditions will mix office work and on-the-floor (cleanroom) production support.  May require occasional off-shift and/or weekend support (< 10%)

COMPETENCIES

• Strong knowledge of pharmaceutical manufacturing processes
• Working knowledge of Good Manufacturing Practices (US and EU)
• Ability to quickly understand detailed and complex processes
• Computer proficiency with JMP, Microsoft Word, Excel, PowerPoint

Physical Requirements:

• Occasional periods of repetitive motion.
• Ability to gown in an aseptic manner for clean room operations. 
• Walking, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required. 
• Ability to operate all types of production equipment 
• Ability to read, understand, and follow company SOP guidelines.
• Ability to lift/move up to 50 lbs.  Ability to team lift up to 100 lbs.
• Ability to stand in steel-toed shoes for a minimum of 7 hrs. 

EDUCATION AND EXPERIENCE

Basic Requirements

• BS Degree or equivalent experience
• 1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting

Preferred Requirements

• BS Degree in Engineering, Chemistry or Biology
• Experienced working on (and coordinating of) multiple projects in an orderly and efficient manner while consistently meeting established deadlines.
• Experienced in working successfully across departments to meet company objectives.