GMP Manufacturing Technician III

- Regular/Permanent

- USA / Texas

- In Office

Welcome to Orano

Helping to meet current and future challenges to preserve our world and build the world of tomorrow while taking care of everyone's health is stimulating for you. For us too. By joining the Orano Group, a leading international player in the nuclear industry, you are in the right place.

Every day we work to produce efficient low-carbon energy, to fight global warming, to find solutions that save natural resources, and to contribute to progress in health.

Our strengths? Across the entire fuel cycle, we have extensive expertise in cutting-edge technologies, safe, high value-added products and services, and a strong capacity for innovation. All of these factors reflect the strong skills of our 17,000 employees, whom we are constantly striving to develop. With their different backgrounds and experience, they are proof of our openness to all talents. They share the same ambition: to give nuclear energy its full value.

Job description

Orano Med Theranostics

Orano Med is seeking a detail-oriented GMP Manufacturing Technician III

We are seeking a highly motivated GMP Manufacturing Technician who will be responsible for non-clinical GMP manufacturing, maintaining the GMP suite and GMP equipment, as well as ensuring that all necessary documentation is maintained accurately in accordance with all applicable regulations. The GMP Manufacturing Technician assists with clinical material manufacturing as well as preparation for clinical product manufacturing. This position conducts routine maintenance of areas and equipment and maintains accurate records of operations within GMP suite.

Key Responsibilities

- Follow written procedures for non-clinical manufacturing

- Complete batch records, forms, equipment logs, and other production records as directed per company procedures and GMP guidelines

- Work concurrently with Quality Assurance (QA) and Quality Control (QC) personnel to deliver a high-quality product

- Follow and adhere to production schedules and timelines

- Execute room and equipment preparation for manufacturing operations

- Perform room sanitization activities as needed to maintain controlled environment conditions

- Participate in isolator and room monitoring

- Participate in room and isolator preparation for manufacturing

- Stocking materials in the GMP labs

- Identify and communicate process and equipment failures during manufacturing to supervisor and equipment team

- Identify process errors and report to supervisor

- Participate in deviation investigations and follow management guidance for corrective and preventive actions

- Clean, sanitize and sterilize equipment and components to support production operations

- Initiate cleaning procedures for the labs, perform routine maintenance on equipment, restock labs.

- Demonstrate ability to perform tasks with minimal guidance once trained

- Complete training on Master Batch Records, Formulation Records, and Protocols related to non-clinical manufacturing

- Complete on the job training for cleaning, gowning, GMP suite access, and equipment

- Primary operator for release testing of cold vials/syringes and solutions

- Monitoring of materials stock, requesting orders, obtaining relevant documents and submitting for release

- Assist in troubleshooting process errors

- Suggest corrective actions in support of deviation investigations

- Assist in editing non-clinical process & equipment documents

Orano strives to provide a total compensation package that brings value to our employees. We also offer highly competitive health and wellness programs, 401(k) contributions, and industry leading paid time off.

Our Full-Time Benefits

- Competitive compensation

- Health, Dental, and Vision insurance – with generous employer contributions

- 401(k) with employer matching and contribution amounts

- Life insurance and Short- and Long-Term Disability insurance provided by the company

- Generous Paid Time Off and holiday schedules

- Numerous Training and Development opportunities

- and more…

Ideal qualifications

Education & Experience

All candidates must meet the following minimum requirements in order to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.

Minimum Qualifications:

- Associate degree in a related field or comparable work experience

- 3+ years applicable work experience

Required Skills & Competencies:

- Chemistry or Microbiology lab experience, knowledge of chemical safety and lab hygiene

- Ability to work side by side with the quality assurance department.

- Excellent documentation skills and attention to detail

- Excellent communication, problem-solving and organizational skills

- Ability to follow written and verbal instruction and work under supervision

- Computer literacy and proficiency with Microsoft Office

- Ability to understand and exercise basic mathematical calculations and more complex calculations with various available tools and calculators

- Ability to work in a very fast-paced, high-growth team environment

- Ability to perform duties using proper aseptic technique

Preferred Skills & Competencies:

- Radiopharmaceutical manufacturing experience

- Communications Skills, Ability to Learn, Initiative, Dependability, Productivity, Quality of Work, Safety, Teamwork.

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, age, disability, citizenship, veteran status, marital status, sexual orientation, gender identity, genetic predisposition or carrier status or any other characteristic protected by law.