Manufacturing Engineer - All Other Locations - Abacus Service Corporation
Pompano Beach, FL 33069
About the Job
Skills
No record(s) found.
Education/Persona
Job Description & Requirements
Responsibilities:
" Interfaces with Quality Assurance, Production, and Engineering departments on process requirements for new and current products.
" Equipment qualification including automation and computerized systems.
" Writes and executes evaluation protocols for all processing steps.
" Analyzes and interprets protocols to prepare additional documentation to support the project.
" Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
" Prepare/edit all types of documentation (batch records, SOPs, protocols, summary reports, etc.)
" Writes final reports and assures they are approved through proper channels.
" Trains Production and Quality Assurance personnel as required.
" Attends Daily Meetings to provide updates as well as take away any actions.
" Performs related duties as assigned.
Qualifications:
Job Requirements:
Experience of 1-3 years experience in a cGMP-regulated manufacturing environment or an equivalent combination of training and experience is required. Bachelor's degree in engineering or a related field of specialization.
Industrial engineering is preferred, but not required.
" Process Validation
" Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements.
" Speak and write fluent English with proficiency in technical writing for complex reports and regulatory documents.
" Interpret specifications, standard operating procedures, and standard testing procedures
" Works as a member of a team to achieve all outcomes
" Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)
" Performs assessments/approvals of change controls related to production activities
Requestor & Work Location
Attachment:
Manufacturing Engineer
Job Responsibilities:
" Interfaces with Quality Assurance, Production, and Engineering departments on process requirements for new and current products.
" Equipment qualification including automation and computerized systems.
" Writes and executes evaluation protocols for all processing steps.
" Analyzes and interprets protocols to prepare additional documentation to support project.
" Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
" Prepare / edit all types of documentation (batch records, SOPs, protocols, summary reports, etc.)
" Writes final reports and assures they are approved through proper channels.
" Trains Production and Quality Assurance personnel as required.
" Attends Daily Meetings so as to provide updates as well as take away any actions.
" Performs related duties as assigned.
Knowledge of:
" Process Validation
" Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and other regulatory requirements.
" Speak and write fluent English with a proficiency in technical writing for complex reports and regulatory documents.
" Interpret specifications, standard operating procedures, and standard testing procedures
" Works as a member of a team to achieve all outcomes
" Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)
" Performs assessments / approvals of change controls related to production activities
Job Requirements:
Experience of 1-3 years' experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.
Bachelor's degree in engineering or a related field of specialization.
Industrial engineering preferred, but not required.
No record(s) found.
Education/Persona
Degree Type | Major/Certification | Required | Preferred |
---|---|---|---|
Bachelor's Degree | Engineering or other related specializations |
Job Description & Requirements
Job Type: | Recruited Resource - General Temp | Number of Positions: | 1 |
System Location: | MTS - 6103 | Created Date: | 3/11/2024 |
Job Title: | Manufacturing Engineer - All Other Locations | ||
CWR Type: | W-2 | Reason: | New Position |
Responsibilities:
" Interfaces with Quality Assurance, Production, and Engineering departments on process requirements for new and current products.
" Equipment qualification including automation and computerized systems.
" Writes and executes evaluation protocols for all processing steps.
" Analyzes and interprets protocols to prepare additional documentation to support the project.
" Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
" Prepare/edit all types of documentation (batch records, SOPs, protocols, summary reports, etc.)
" Writes final reports and assures they are approved through proper channels.
" Trains Production and Quality Assurance personnel as required.
" Attends Daily Meetings to provide updates as well as take away any actions.
" Performs related duties as assigned.
Qualifications:
Job Requirements:
Experience of 1-3 years experience in a cGMP-regulated manufacturing environment or an equivalent combination of training and experience is required. Bachelor's degree in engineering or a related field of specialization.
Industrial engineering is preferred, but not required.
" Process Validation
" Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other regulatory requirements.
" Speak and write fluent English with proficiency in technical writing for complex reports and regulatory documents.
" Interpret specifications, standard operating procedures, and standard testing procedures
" Works as a member of a team to achieve all outcomes
" Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)
" Performs assessments/approvals of change controls related to production activities
Requestor & Work Location
Requested by: | N/A | Alternate: | N/A | |||||||||||||||||||
Report To: | N/A | |||||||||||||||||||||
Phone: | N/A Ext.:N/A | |||||||||||||||||||||
Travel Required: | How Much Travel? | |||||||||||||||||||||
Report To Manager's Office Address | 1295 SW 29th Avenue USPOM, Pompano Beach, FL 33069 United States | |||||||||||||||||||||
Start Date: | 3/25/2024 | Work Days: |
| |||||||||||||||||||
End Date: | 3/25/2025 | |||||||||||||||||||||
Start Time: | 8:00 AM | Total Reg Hours: | 40.00 | |||||||||||||||||||
End Time: | 5:00 PM | Overtime Required: | ||||||||||||||||||||
Lunch Time: | 1 Hour | |||||||||||||||||||||
Exempt: | Open Bid: |
Attachment:
Manufacturing Engineer
Job Responsibilities:
" Interfaces with Quality Assurance, Production, and Engineering departments on process requirements for new and current products.
" Equipment qualification including automation and computerized systems.
" Writes and executes evaluation protocols for all processing steps.
" Analyzes and interprets protocols to prepare additional documentation to support project.
" Analyzes data to determine if it meets protocol acceptance criteria. Writes deviation reports as required upon failures to meet acceptance criteria.
" Prepare / edit all types of documentation (batch records, SOPs, protocols, summary reports, etc.)
" Writes final reports and assures they are approved through proper channels.
" Trains Production and Quality Assurance personnel as required.
" Attends Daily Meetings so as to provide updates as well as take away any actions.
" Performs related duties as assigned.
Knowledge of:
" Process Validation
" Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA) and other regulatory requirements.
" Speak and write fluent English with a proficiency in technical writing for complex reports and regulatory documents.
" Interpret specifications, standard operating procedures, and standard testing procedures
" Works as a member of a team to achieve all outcomes
" Recommends and monitors improvements in manufacturing and control systems including corrective and preventative actions (CAPA)
" Performs assessments / approvals of change controls related to production activities
Job Requirements:
Experience of 1-3 years' experience in a cGMP regulated manufacturing environment or an equivalent combination of training and experience is required.
Bachelor's degree in engineering or a related field of specialization.
Industrial engineering preferred, but not required.
Source : Abacus Service Corporation