The Manufacturing Technician has primary responsible for the activities and procedures which are required to formulate and fill products. The position follows established procedures in the execution of daily activities.
Strategic Focus Areas:
1. Prepare and operate production equipment maintaining a high level of safety and quality for the manufacturing of medical device products.
2. Execute work activities ensuring compliance to standard operating procedures in accordance to cGMP guidelines and other regulatory standards
3. Participate in projects and activities that support the growth efforts of the Company
Specific Tactical Responsibilities:
1. Execute manufacturing directions involving dissolution, reaction, filtration, formulation and fill activities for aseptic and terminally sterilized products
2. Adhere strictly to written work instructions to perform clean out of place, clean in place, steam in place and autoclaving of complex equipment and components
3. Perform room sanitization activities to maintain controlled environment conditions
4. Perform other job specific standard operating procedures that support batch record and written work instruction execution
5. Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
6. Document and verify manufacturing and quality information on controlled forms and batch records.
7. Reports procedural deviations and nonconformance to management
8. Performs room owner activities ensuring work areas are maintained in proper conditions.
The position works on assignments that are routine in nature where cGMP experience is required in order to perform work activities. The Manufacturing Technician normally receives instruction on routine work and detailed instructions and training on new assignments.
1. AS with 2+ years’ experience or HS diploma with 4 years of experience in cGMP manufacturing
2. The candidate must possess the ability to read, write and verbally communicate in English
3. Ability to work flexible hours to complete work activities
Desired Experience, Knowledge, and Skills:
1. 4+ years previous experience in commercial regulated approved manufacturing facility
2. Experience working in a clean room using aseptic technique
3. Experience using commercial scale automated equipment
4. Experience in a results driven, team environment