Manufacturing Process Technologist

2 months ago

Wilmington, United States Alkermes Full time

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

Develops and maintains databases which provide trending capability for process parameters

Develops and maintains (tracks) Vivitrol production metrics through use of analytical tools

Conducts frequent and thorough periodic reviews of database and trends, identify opportunities for improvement in performance both in process, manpower effectiveness and efficiency

Actively identifies unfavorable trends and investigates root cause as well 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

Provides 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 regards 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

Working conditions will be a mix of office work and on-the-floor (cleanroom) production support. May require occasional off-shift and/or weekend support (< 10%)

EDUCATION AND EXPERIENCE:

Manufacturing Process Technologist

Basic Experience

BS Degree or equivalent experience

1-2 years in manufacturing, process development, or engineering in a pharmaceutical setting

Preferred Experience

BS Deegree in Engineering, Chemistry or Biology

Experienced working on (and coordination of) multiple projects in an orderly and efficient manner, while consistently meeting established deadlines

Experienced in working successfully across departments to meet company objectives

Sr. Manufacturing Process Technologist

Basic Experience

BS Degree or equivalent experience

5+ years in manufacturing, process development, or engineering in a pharmaceutical setting

Preferred Experience

BS Deegree in Engineering, Chemistry or Biology

Experienced working on (and coordination of) multiple projects in an orderly and efficient manner, while consistently meeting established deadlines

Experienced in working successfully across departments to meet company objectives

SKILLS/ABILITIES:

Ability to lift/move 50lbs. overhead; Ability to team-lift 100 lbs.

Ability to operate all types of production equipment

Ability to self-manage and prioritize work load

Ability to gown properly for clean room operations

Ability to read, understand and follow company SOPs and guidelines

Ability to stand or sit for extended periods of time (up to 2 hours at a time)

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

Must be able to work in office and manufacturing environment

Some travel required (< 10%)

PERSONAL ATTRIBUTES:

Dependable, well-organized, efficient

Detail and results oriented

Motivated self-starter; Willing to learn new tasks, skills

Works well in a team environment

Strong oral and written communication skills

Responds quickly to assignments; Readily adapts to changing job duties

Manages time well; Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines

Ability to work cross-functionally to meet company objectives

Positive attitude; Displays understanding of and promotes company objectives

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