API Manufacturing Technician

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 material‑handling 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
• - Authorization to work in the United States indefinitely without restriction or sponsorship
• 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

• After the initial training period of approximately 3 months which will be Monday- Friday from 8am-5pm team members move to swing shift, which alternates between 1st shift and 2nd shift:
• - 1st Shift is Mon-Fri, 6:00 am to 2 pm
• - 2nd Shift is Mon – Thurs, 2 pm to 12 pm
• 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.
• Able 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