What are the responsibilities and job description for the Production Operator II position at Curia?
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Contribute to the creation and distribution of treatments that enhance lives. Make medicines more accessible. And help breakthroughs break through faster. At Curia, a global contract research, development, and manufacturing organization, our impact is real. So is your opportunity for a significant, satisfying career. As an employer of choice supporting the top 10 pharmaceutical companies, we offer numerous career advantages. In addition to competitive pay and meaningful benefits, you’ll enjoy the empowerment to be the difference, the chance to work with a diverse team of talented people, a culture that inspires success, and an award-winning workplace. Stop waiting for your future to arrive. Shape it every day with Curia.
Summary:
Elevated experience in support of timely manufacturing of parenteral cGMP products in an aseptic environment including: basic setting up of equipment, learning how to properly operate equipment, sanitize and sterilize equipment and manufacturing areas; preparations , component washing, vial washing and sterilization of vials. Sanitize aseptic and controlled areas utilizing specialized solutions and equipment. Perform sterile processing of equipment following sanitization procedures. Complete all sanitization and documentation in accordance with Standard Operating Procedures (SOPs).
Essential Duties and Responsibilities:
- Prepare and sanitize equipment for clean rooms, product compounding, and filling according to preparation list this includes disassembly/assembly
- Load and unload vial washers, prepare filters and transfer assemblies according to proper diagrams and instructions
- Record all procedures in logbooks following completion and complete/correct batch records to ensure readiness for filling Operations
- Sanitize aseptic/controlled production areas to ensure microbial contamination is reduced to safe level on inanimate surfaces
- Bubble point test filters and read/interpret SOPs to ensure compliance
- Other duties as assigned
Supervisory Responsibilities:
This job has no supervisory responsibilities.
Education and/or Experience:
High school diploma or general education degree (GED); and 3 year’s related experience (production, manufacturing, and/or clean room experience preferred) and/or training; or equivalent combination of education and experience.
Language Skills:
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Mathematical Skills:
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
Reasoning Ability:
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Computer Skills:
Knowledge of Internet software; Manufacturing software; Spreadsheet software and Word Processing software.
Other Skills and Abilities:
- Comprehend and follow SOPs, cGMPs, and detailed instructions to successfully produce sterile quality products.
- Document information, events, and cGMP manufacturing processes clearly, accurately and completely.
- Perform duties in an organized, detail oriented manner.
- Apply basic math: measures, weights, fractions, decimals.
- Apply basic computer skills.
- Work and communicate well with others in a team environment.
Other Qualifications:
Must pass background check
Must pass drug screen
Pass Wonderlic Basic Skills Test at 12th grade level or higher
COVID-19
U.S. employees of Curia Global Inc. and its subsidiaries (a “ Compan y”) hired after December 7, 2021 must be fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of their employment except for U.S. employees who request and qualify under applicable law for disability and religious accommodations from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S. employee will be required to provide proof of vaccination, or to request and receive a disability or religious accommodation that the applicant is entitled to under applicable law, before their first day of employment or any earlier or later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law.
Physical Demands:
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand; walk; reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision and depth perception.
Work Environment:
While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
All interested applicants must apply online. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.