Simtra BioPharma Solutions
Healthcare
FormulationGroupLeaderWeekendPM
“Formulation Group Leader Weekend PM at Simtra BioPharma Solutions. Skills: Formulation, Manufacturing, Quality Assurance, Leadership. Prepare media and buffer solutions. Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems”
What You'll Achieve.
ensure that finished products meet the required specifications; ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures; fully supports and drives quality operations on the production floor; creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.
Industry & Context.
solve problems in new ways; Troubleshoot process problems
Weekend PM Schedule: Friday-Sunday 7:00pm-7:30am, Classified pharmaceutical environment wearing required gowning., Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions., Must be able to occasionally (1-33% of the time) work in a confined/clustered work space., Occasional (1-33%) Sitting, climbing stairs and ladders, balancing, kneeling, operating controls, Frequent (34-66%) Standing, walking, reaching forward and overhead, stooping, crouching, Pushing and pulling up to 110 lbs Lifting and carrying up to 70 lbs, Constant (67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping, Final candidates for Formulation Group Leader will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.
What They're Looking For.
Must Have
Ability to work independently, Good communication skills, Good documentation skills, including legible handwriting, Good interpersonal skills, Basic computer skills, Basic math skills, Knowledge of aseptic manufacturing practices, Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert, Requires the operations of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices, Must be able to understand, speak, read and write English
Nice to Have
6 months of previous Pharmaceutical or Manufacturing experience
What You'll Do.
Prepare media and buffer solutions
Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) systems
Operate general production equipment
Monitor and record critical process parameters
Complete all relevant paperwork following GDP/GMP guidelines
Perform routine maintenance and cleaning of production equipment
Perform sampling using aseptic techniques
Participate on Continuous Improvement Teams
Train and mentor other team members
revise and review pertinent documentation
Troubleshoot process problems and respond to process alarms
Assist with process/equipment validation and data analysis
Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
Maintain attendance in accordance with the Bloomington Attendance Policy
Scheduled weekend overtime will be required
How You'll Work.
Team & Collaboration
Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.; communicates effectively with production team members, multiple levels of management, and other customer support departments.; Work with other groups such as maintenance/metrology and calibration to ensure preventative maintenance completion
Communication Scope
Good communication skills; communicates effectively with production team members, multiple levels of management, and other customer support departments.; Must be able to understand, speak, read and write English
Process & Methodology
Participate on Continuous Improvement Teams
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