Manufacturing Technician

Renesas Electronics; Groton (CT); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a dedicated professional to join their team in Groton, CT. The role involves executing manufacturing processes in a cGMP environment, supporting equipment validation, and ensuring product quality. Ideal candidates will have strong problem-solving skills and experience in a manufacturing setting. Comprehensive benefits and a supportive work environment are offered.

Benefits

Comprehensive medical coverage

Dental options

Vision options

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Qualifications

• 4+ years of relative experience in a cGMP manufacturing environment.
• Demonstrated capability to work as an independent contributor within a matrix development team.

Responsibilities

• Execute Process Operating Instructions in a cGMP environment.
• Support equipment validation and commissioning activities.
• Generate documentation associated with cGMP API manufacture.

Skills

Troubleshooting

Problem Solving

Communication

Organization

Attention to Detail

Education

High School Diploma or GED

Associate degree (Science or technical discipline)

Tools

Microsoft Office

Delta V Production Control System

Job description

Job Description

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: solid / liquid charges, atmospheric / vacuum distillations, filtrations, liquid-liquid 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 cross-functional 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 in-process 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 less-experienced colleagues.

Qualifications:
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
• 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 Monday-Friday 8:00 am- 5:00 pm Overtime as needed. Candidates currently living within a commutable distance of Groton, CT are encouraged to apply.

• 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.