API Manufacturing Technician
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Job Location:
New London County, CT - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
You will be part of a multi-disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non-commercial 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 these operational tasks: solid / liquid charges to vessels atmospheric / vacuum distillations liquid-liquid extractions phase cut crystallization filtrations and drying.
ROLE RESPONSIBILITIES
- Execute Process Operating Instructions in a cGMP part of GxP environment.
- Responsible for equipment preparation operational adjustment process monitoring sampling and equipment cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures.
- Perform manual handling tasks including lifting carrying and moving objects weighing up to and exceeding 50 pounds on a routine basis throughout the work shift using proper materialhandling techniques and safety practices.
- Handle and segregate manufacturing waste in accordance with approved waste management environmental and safety requirements.
- Support equipment qualification/ commissioning activities.
- Adhere to cGMP and standard and local 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 cross-functional communication with tech transfer team: Compliance 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 and cleaning documentation and in-process control sampling.
- Support Standard Operating Procedure Periodic Reviews.
- Report any deviations or observations that might lead to adverse impact on product quality or process safety.
- 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 less-experienced 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 problem-solving 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
- Candidate must be physically capable of standing for prolonged periods able to lift up to or in excess of 50 lbs be amenable to wearing personal protective equipment and working with hazardous materials.
- 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 :
- The position is full-time Monday through Friday 8 a.m. to 5 p.m.
- May be requested to work on weekends overtime and holidays based on business needs.
- Candidates currently living within a commutable distance of Groton CT are encouraged to apply.
- Ability to work overtime as required.
- Excellent full-time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
- #LI-EB1
- 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 :
Full-time
Key Skills
- Lean Manufacturing
- Hand Tools
- Basic Math
- Math
- Mechanical Knowledge
- Assembly Experience
- Computer Literacy
- Schematics
- cGMP
- Clamp Truck
- Programmable Logic Controllers
- Manufacturing
About Company
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and the environment safer, healthier and more sustainable. From the food you eat to the medicines you rely on, Eur ... View more
