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11 days ago
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Process Manufacturing Engineer I


Salary band: $10k - $15k
Location: North America, United States, Massachusetts
Job type: Permanent
Contact: Pharmalucence
Category: Engineer
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Summary
Coordinate and/or implement process equipment/utilities maintenance and maintenance according to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs).

Responsibilities and Tasks
Responsible for maintenance and operation of process equipment as well as associated documentation
Support execution of preventative maintenance of pharmaceutical process equipment and utilities
Ensure that the equipment is prepared to support the production schedule and is in proper condition/calibration
Provide 24/7 operational coverage for manufacturing equipment and utilities
Support production personnel on equipment and utility operation
Support PM re-qualification of process equipment, testing & certifications of manufacturing process
Support area manufacturing and new product/process transfer activities
Follow up on equipment/utility related CAPAs, Deviations, and Investigations
Review process utilities and equipment logs
Oversee loading / lyophylization cycle and coordination of equipment
Troubleshoot and remediate exceptions found during FAT/SAT/IQ/OQ/PQ
Ensure timely closure of equipment/utility related CAPAs and/or Change Controls
Support Validation of equipment/utilities/process transfers and re-qualifications
Support URS/FS/DS engineering documents of process related systems
Other duties as assigned.
Knowledge Skills and Abilities
Ability to oversee cGMP validation compliance efforts
Ability to operate and maintain process equipment and utilizes (Sterilizers, Depyrogenation Ovens, Lyophilers, Incubators, CTUs)
Familiarity with FDA cGMP, SOPs and ISO standards
Knowledge of pharmaceutical manufacturing equipment and utilities
Familiarity/Knowledge of aseptic techniques
Excellent organizational skills

Education and Experience
Bachelors in Science, Engineering or related field preferred or equivalent experience
Minimum 2+ years related experience preferred

Pharmalucence is an Equal Opportunity Employer
Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you need help applying online, please contact (please use the apply button below) or call
Joyce, HR Assistant at

Type: Full-time.

To apply, please e-mail your resume to (please use the apply button below) or mail to (please use the apply button below) or use the 'apply now' button below:

Summary
Coordinate and/or implement process equipment/utilities maintenance and maintenance according to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs).

Responsibilities and Tasks
Responsible for maintenance and operation of process equipment as well as associated documentation
Support execution of preventative maintenance of pharmaceutical process equipment and utilities
Ensure that the equipment is prepared to support the production schedule and is in proper condition/calibration
Provide 24/7 operational coverage for manufacturing equipment and utilities
Support production personnel on equipment and utility operation
Support PM re-qualification of process equipment, testing & certifications of manufacturing process
Support area manufacturing and new product/process transfer activities
Follow up on equipment/utility related CAPAs, Deviations, and Investigations
Review process utilities and equipment logs
Oversee loading / lyophylization cycle and coordination of equipment
Troubleshoot and remediate exceptions found during FAT/SAT/IQ/OQ/PQ
Ensure timely closure of equipment/utility related CAPAs and/or Change Controls
Support Validation of equipment/utilities/process transfers and re-qualifications
Support URS/FS/DS engineering documents of process related systems
Other duties as assigned.
Knowledge Skills and Abilities
Ability to oversee cGMP validation compliance efforts
Ability to operate and maintain process equipment and utilizes (Sterilizers, Depyrogenation Ovens, Lyophilers, Incubators, CTUs)
Familiarity with FDA cGMP, SOPs and ISO standards
Knowledge of pharmaceutical manufacturing equipment and utilities
Familiarity/Knowledge of aseptic techniques
Excellent organizational skills

Education and Experience
Bachelors in Science, Engineering or related field preferred or equivalent experience
Minimum 2+ years related experience preferred

Pharmalucence is an Equal Opportunity Employer
Individuals with Disabilities and Protected Veterans are encouraged to apply.
If you need help applying online, please contact (please use the apply button below) or call
Joyce, HR Assistant at

Type: Full-time.

To apply, please e-mail your resume to (please use the apply button below) or mail to (please use the apply button below) or use the 'apply now' button below:


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