Manufacturing Technician
Manufacturing Technician
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
You will be part of a multidisciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of noncommercial size clinical batches supporting Active Pharmaceutical Ingredient (API) development. This includes but is not limited to: supporting the manufacturing operations team reviewing Standard Operating Procedures executing batch records and supporting commissioning and qualification of process equipment. Standard work will involve chemical synthesis of API which includes: solid / liquid charges atmospheric / vacuum distillations filtrations liquidliquid extractions isolations drying purification and milling.
ROLE RESPONSIBILITIES
- Execute Process Operating Instructions in a cGMP part of GxP environment.
- Responsible for equipment preparation and cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.
- Support equipment validation / commissioning activities.
- Adhere to cGMP and standard operating procedure requirements.
- Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
- Identify opportunities for continuous improvements and enable implementation.
- Maintain crossfunctional communication with tech transfer team: Quality Process Chemists Analysists and Process Supervisors.
- Perform troubleshooting of manufacturing support equipment and operations.
- Generate assist and execute documentation associated with cGMP API manufacture such as: working batch record documentation and inprocess control sampling.
- Support Standard Operating Procedure Periodic Reviews.
- Report any deviations or observations that might lead to adverse impact on product quality.
- Actively participate in shift exchange activities and communication channels.
- Complete training to take part in safety inspections within the facility.
- Manage own time professional development and be accountable for own results.
- Prioritize own workflow and assist in prioritizing the workflow of lessexperienced colleagues.
Qualifications :
BASIC MINIMUM QUALIFICATIONS
- High School Diploma or GED
- 4 years of relative experience
- Demonstrated experience in a cGMP manufacturing environment.
- Operational knowledge of Production Control Systems
- Ability to think critically and demonstrate troubleshooting and problemsolving skills
- Strong workload planning skills organization attention to detail and follow through
- Demonstrated capability to work as an independent contributor within a matrix development team
- Excellent written and verbal communication skills
- Strong computer skills in Microsoft Office required e.g. MS Word MS Excel
PREFERRED QUALIFICATIONS
- Associate degree (Science or technical discipline)
- Strong mechanical aptitude and desire to execute hands on manual labor
- Experience with Delta V Production Control System
- Experience in a Pharmaceutical cGMP manufacturing environment
- Experience performing large scale distillations / Filtrations / milling
Additional Information :
Position is MondayFriday 8:00 am 5:00 pm Overtime as needed. Candidates currently living within a commutable distance of Groton CT are encouraged to apply.
- Excellent fulltime benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- #LIEB1
- Authorization to work in the United States indefinitely without restriction or sponsorship
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
