Manufacturing Associate

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This position reports to Nights, 6:00 pm – 6:30 am, 2-2-3, 12.5 hours shift, off every alternate weekend. Due to business need, on select occasions, employees may be required to work overtime.

With general supervision the Manufacturing Associate will perform routine and critical manufacturing operations, including but not limited to work functions in Cell Culture, Purification, and Solution & Equipment Prep areas. Will operates production equipment according to SOPs to produce clinical and/or commercial products.

Responsibilities:

80%

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Records and Form Preps. Responsibilities include

• Troubleshoot and resolve process related issues

• Initiate and document minor deviations

• Execution of critical and routine production operations

• Perform Batch Record, Log Book, and Form Prep request

• Enter data in the Laboratory Information Management System (LIMS)

• Record data into log books

• Review log books data

• Sample preparation and testing

• Propose document revisions

• Carry out work in a safe manner, notifying management of safety issues and risks

10%

This individual will manage equipment and support facility related projects by

• Initiating work orders

• Perform scheduled cleaning of equipment

• Assembly and disassembly of process equipment

• Perform standardization of equipment

• Support change over activities

• Execution of equipment and process qualifications and validation

10%

Staff Technical Training and Development

• Meet and maintain training requirements

• Develop and maintain personal development plan

• Provide annual performance self-assessment on development plan

Education and Experience Requirements

Minimum

• High School diploma or an Associate’s Degree in Life Sciences/Engineering field with 1 years of GMP Manufacturing experience.

• 0 - 4 years related industry experience

Desired:

• Biotech Certificate preferred

• Prior experience in the following activities:

  • Standardization and measurements utilizing bench top equipment (i.e pH meter, osmometer, conductivity meter, etc)

  • Process automation

  • Basic Ultra filtration knowledge

  • Basic Cell culture knowledge

Key Skills, Abilities, and Competencies

Significant understanding of the general aspects of the job, with a broad understanding of the detailed aspects of the job.

• May be required to perform as a subject matter expert for equipment and/or systems

• Proficient at following written instruction in the form of Batch Records, Form Preps, Technical Protocols and Procedures

• Possess excellent communication and troubleshooting skills

• Full awareness of current Good Manufacturing Practices

• Proficient computer skills

• Will work holidays and overtime as required

• May be required to adjust work schedule to meet production demands

• Proficient in Aseptic Technique

• Ability to work cohesively in a team environment

• Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes

• Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas

• Ability to lift, pull, or push equipment requiring up to 25-50 lbs. of force

• Ability to stand for 6 hours in a production suite

• Ability to climb ladders and work platforms

• Stooping or bending to check or trouble-shoot equipment operations

• Ability to work around chemicals (alcohols, acids & bases)

Complexity and Problem Solving

Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making decisions

• Basic troubleshooting skills

• Receives assignments in the form of objectives with goals and process to meet goals outlined.Work is reviewed by supervisor to measure meeting of objectives

• Accomplish tasks mainly through direct operation of cGMP activities

• Performs daily operations of the work unit and actively assists coworkers in fulfilling department goals elevating issues to senior staff

• Evaluate and elevates issues to senior staff

• Identifies process deviations, troubleshoots issues and identifies process improvements

USA - MA - Lexington - BIO OPS

Employee

Regular

Full time

Job ID R0027901