Manufacturing Technician II

Description:

Shift: Sunday to Wednesday shift, 7:00am - 5:30pm.

Top 3-5 skills needed

• Performs functions associated with cGMP manufacturing operations within the biologics production facility
• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.
• Sampling of in process and raw materials, Running glass washer / autoclave, Buffer / media preparation, Equipment preparation (CIP/SIP), Aseptic practices, Column chromatography, Tangential flow filtration

Possible temp to perm position - Y

Number of Interviews (recommend minimizing) - 2

Reason for request - Additional capacity needed

What are the top 3-5 skills, experience or education required for this position:

• Performs functions associated with cGMP manufacturing operations within the biologics production facility
• Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment.
• Sampling of in process and raw materials, Running glass washer / autoclave, Buffer / media preparation, Equipment preparation (CIP/SIP), Aseptic practices, Column chromatography, Tangential flow filtration

Years of experience/education and/or certifcations required:

• 3 minimum anything manufacting related, pharmac manf a plus.
• GMP practices
• Mechanical skills
• Any work in a clean room would be a bonus
• They can train in any gaps, but any of the pieces would be a plus.

Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?

This position is responsible for maintaining fibroblast cell cultures in various platforms to produce Fibroblast Conditioned Media. Collect and sample fibroblast conditioned media and to manufacture solutions used during the cell culture process. Support cell culture activities, such as: assisting with the cleaning and sterilization of all components, containers, and associated equipment used in the production department.

Main Areas of Responsibilities

• Maintain human fibroblast cell culture of human fibroblast in a clean room environment as directed by manufacturing schedules within standard times and according to established procedures.
• Assist in the manufacture of solutions used in production and processing of raw materials.
• Sample by-products using standard methodologies.
• Complete all relevant documentation compliant with cGMP and GDP guidelines
• Maintenance of the cell culture complex and surrounding environment (i.e. refrigerators, freezer, warm room, etc.)
• Assist in the organization and housekeeping of the washroom and production support areas.
• Assist in the cleaning of autoclavable materials used during cell culture.
• Assist in the maintenance of cell expansion cultures.
• Maintain a clean and safe work area and report unsafe conditions to management.
• Assist in the assembly of cell culture roller bottles
• Perform other duties as assigned

Please note: open toe shoes, shorts, jewelry, make-up, false eyelashes, fake nails or hats are not allowed in this role

Are you open to look at candidates willing to relocate?

• Yes, at candidate expense

Years of experience/education and/or certifications required:

• Bachelor's degree preferably in a Natural Science, Cell Biology, Biology, Biochemistry, Chemical Engineering or a related field. Associate degree from an accredited two-year program with relevant work experience will be considered.
• 3-5 years of relevant experience

What are the top 3-5 skills requirements should this person have?

• Schedule management
• Attention to detail
• Willingness to learn

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Experience working with mammalian cell cultures in a cleanroom environment
• Strong understanding of biology, including animal organisms, their tissues, cells and cell-cell interactions and function.
• Intermediate problem-solving attitude
• High level of mathematical skills
• Experience working in a GMP regulated environment
• Aseptic Technique (clean room)

What type of environment is this person working in?

• Clean Room - full head to toe gowning

Adept at written and verbal communication. Communicates ahead of time when time commitments can not be met. References, populates and maintains visual management tools. Responds to written requests (i.e. replies to emails) in a timely manner. Must be able to follow written instructions in excess of 20 pages. Computer literacy is required for this role. Education: AS Degree or equivelent expereience required Duties: Performs functions associated with cGMP manufacturing operations within the biologics production facility, including working with engineers in set-up and calibration tasks, as well as performing rework and quality testing related to the production of parts, components and final materials. Uses sophisticated programs (such as LIMS, SAP, automated control systems, etc.) to collect and evaluate operating data, which can be used to conduct on-line adjustments to products, instruments or equipment. Determines and may assist in developing methods and procedures to control or modify the manufacturing process.

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