Manufacturing Technician I/II/III - MA (1st Shift)

JOB SUMMARY

Manufacturing performs all required process steps and in process controls, in close collaboration with MSAT, QC, QA, Engineering and Validation.

With general supervision the individual will perform routine and non-routine manufacturing operations, including but not limited to work functions in Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment according to SOPs for the production of clinical and/or commercial products. 

This position is located in Lexington, MA and reports to the MFG Supervisor.

ESSENTIAL JOB FUNCTIONS

This individual will carry out cGMP manufacturing operations utilizing Standard Operating Procedures (SOP), Batch Production Records and Solution prep records.

Primary responsibilities include the following:

• Attend daily meetings including shift hand off and ensure relevant information is shared between shifts
• Perform weekly/monthly walkthroughs and ensure areas are maintained in a safe and compliant state 
• Maintaining orderliness of process area and stocking production area with supplies from collaboration with Supply Chain
• Demonstrating general knowledge of aseptic techniques 
• Perform troubleshooting activities according to SOPs 
• Execute routine and non-routine production operations according to MFG schedule, including off shift production activities when needed
• Document operations according to GDP principles in Batch Production Record (BPR), Solution records (SLR), Logbooks and Forms   
• Perform page reviews in BPRs, SLRs, Logbooks, and Forms  
• Carry out work in a safe manner, notifying management of safety issues and risks 
• Maintain up-to-date training folder for applicable processes 
• Required to work holidays and overtime as needed to support the manufacturing process

This individual will manage equipment and support facility related projects by:

• Perform scheduled cleaning of equipment 
• Perform standardization of equipment 
• Support product change over activities 
• Support equipment and process qualifications if needed 
• Escalate work requests to Senior or Lead Technicians for submission in work request management system 

Staff Technical Training and Development:

• Propose continuous improvement, process, and human performance document revisions
• Escalate and contributes to process improvement and manufacturing Continuous Improvement items
• Develop and maintain personal development plan
• Provide annual performance self-assessment

SPECIAL JOB REQUIREMENTS

• Normally requires a high school diploma and 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP
• Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
• Preferably working experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization  
• Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes and procedures  
• Hands-on experience in writing and reviewing documentation  
• Experience in (bio)-manufacturing unit operations (USP and/or DSP)
• Good writing and oral communication skills  
• Applies experience and skills to complete assigned work within own area of expertise
• Works within standard operating procedures and/or scientific methods
• Comfortably able to lift up to 40lbs  
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

PHYSICAL DEMANDS

While performing the duties of this job, the employee is required to meet the following physical demands:

Work Environment

• Regularly sit for long periods of time

Movement

• Frequently required to stand; sit; walk; balance; stoop; kneel; crouch; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl

Lifting

• Frequently lift and/or move up to 20 pounds
• Rarely lift and/or move up to 40 pounds

Vision

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail