Manufacturing Operator Job at Smith & Nephew
About Us:
Smith+Nephew has a proud history of more than 160 years of improving health around the world. While we have grown significantly from our beginnings as a small family pharmacy in Hull, England, our caring spirit has remained the same.
Care, Collaboration, & Courage:
Care means that we show empathy and understanding for each other, our customers, and our patients.
Collaboration means we work together as a team, based on mutual trust and respect.
Courage is about continuous learning, innovation, and accountability.
At Smith+Nephew, we offer competitive and rewarding compensation and benefits packages.
Our benefits packages vary from country to country and by level, but often the total package includes the following:
- A competitive salary with an annual incentive bonus scheme.
- Healthcare coverage at most levels.
- A competitive company retirement benefits scheme for all employees.
Role Overview:
The Manufacturing Operator will perform all activities involved in the aseptic
processing of a biologic product, under the direct supervision of the
Manufacturing Supervisor. This position will support the Manufacturing
department by performing tasks that will assure the safe and timely processing
of the product, working in a classified GMP environment.
The Manufacturing Operator will perform all activities involved in the aseptic
processing of a biologic product, under the direct supervision of the
Manufacturing Supervisor. This position will support the Manufacturing
department by performing tasks that will assure the safe and timely processing
of the product, working in a classified GMP environment.
Responsibilities:
> Prepare product, according to production planning and GMP regulations.
Initiate, create, and review batch records and labels and perform regular
checks on the process, following batch records, in order to product to
according to GMPs (10%)
> Responsible for manufacturing a cell-based product according to
established Master Batch Records and Operating Procedures (10 %)
> Responsible for the preparation and in-process testing of all media,
reagents, substrates for testing, and sanitizing agents used in
manufacturing areas (10 %)
> Responsible for proper operation of all clean room equipment. Assist
with maintenance and equipment validation as needed (10 %)
> Responsible for assuring Standard Operating Procedures and Batch
Records are complete and compliant in alignment with processing (10 %)
> Responsible for maintaining all required records to established
guidelines for production procedures, the GMPs, and safety. (10 %)
> Prepare product, according to production planning and GMP regulations.
Initiate, create, and review batch records and labels and perform regular
checks on the process, following batch records, in order to product to
according to GMPs (10%)
> Responsible for manufacturing a cell-based product according to
established Master Batch Records and Operating Procedures (10 %)
> Responsible for the preparation and in-process testing of all media,
reagents, substrates for testing, and sanitizing agents used in
manufacturing areas (10 %)
> Responsible for proper operation of all clean room equipment. Assist
with maintenance and equipment validation as needed (10 %)
> Responsible for assuring Standard Operating Procedures and Batch
Records are complete and compliant in alignment with processing (10 %)
> Responsible for maintaining all required records to established
guidelines for production procedures, the GMPs, and safety. (10 %)
> Responsible for adherence to all Operating Procedures, protocols,
policies, regulatory requirements, the GMPs, and the safety guidelines.
(15 %)
> Regularly execute performance checks on the assigned production
apparatus in order to signal defects as soon as possible. Participate in
environmental monitoring and process validation, when applicable (5 %)
> Perform other duties as required (5 %)
policies, regulatory requirements, the GMPs, and the safety guidelines.
(15 %)
> Regularly execute performance checks on the assigned production
apparatus in order to signal defects as soon as possible. Participate in
environmental monitoring and process validation, when applicable (5 %)
> Perform other duties as required (5 %)
Location: Fort Worth, Texas
Working Days: 2nd Shift, Wednesday through Sunday, and overtime as needed, 3PM - 11:30PM
Education: High school diploma or GED required.
Licenses/ Certifications: None
Experience: 0-1 years experience (cell science experience is preferred)
Competences:
GMP experience is required
Regulated industry experience is required
Physical Demands:
- Ability to lift up to 30 lbs.
- Stand or sit for extended periods of time
- The ability to change into a cleanroom gown
Travel Requirements: No travel required
Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
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