Manufacturing Associate
1 week ago
Manufacturing Associate II (Manufacturing/Quality) 1st Shift
1 Year
Framingham, MA
Shift: Mon - Fri; 6:00am – 4:30pm, some weekend work required; 100% Onsite
Job Responsibilities
- Operate general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines.
- Requires good documentation skills and attention to detail.
- Tasks to be completed may include fermentation, protein purification, solvent extractions, tissue culture, preparation of bulk solutions, aseptic fills of buffers, filling and labeling of vials under sterile and non-sterile conditions, routine buffer and media preparation, filtration, vial preparation and sterilization.
- Operate general manufacturing equipment in strict accordance with SOPs to complete tasks as noted above as well as large scale bioreactor operations, critical small or large volume sterile fills, and aseptic manipulation of cell cultures.
- Operate with minimal supervision complex systems and equipment and optimizes their use in accordance with defined goals.
- May participate in plant trials for evaluating process modifications.
- Troubleshoot processing problems.
- Assist in the implementation of production procedures to optimize manufacturing processes.
- May attend research meetings related to the transfer process of new products.
- May prepare monthly operating reports for use in the analysis of the performance of the unit.
- Participate in authoring complex, explicit documentation for manufacturing operations.
- May provide training to new personnel in a specific technical process.
- Demonstrated ability in the application of requisite skills and applies additional skills and knowledge acquired through experience to perform the more complex tasks of the position.
- Generally receive no instructions on routine assignments while under little or no supervision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Education & Qualifications
• Requires physical demands of lifting up to 30 lbs/14 kg to 35 lbs/16 kg. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May involve work with hazardous materials.
Required:
• Min 1-3 Years of experience in Pharmaceutical Manufacturing
• Experience working with solvents, precipitants, bulk solutions
• GDP, GMP • Excellent attendance and team player
Nice to Have/ Preferred
• Closer to 3 years of experience Steam in Place/ SIP
• Purification experiences a strong plus
• Experience with Filter Integrity Testing (FIT): This is a process that uses instrumentation to ensure the filters used in process are integral pre-use and post-use.
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