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.
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
The Process Expert is responsible for managing production instrumentation, optimization of existing processes, and development of new processes. This scope includes initiation, scheduling, monitoring, and closure according to GMP, safety, and environmental requirements. The Process Expert should set a strong example for: determination to meet ambitious goals/timelines, customer service attitude toward colleagues, and motivation to help cancer patients.
Primary Responsibilities:
- Own or support production documentation, including Master Batch Records, SOPs, risk assessments, protocols, reports, and other documentation as needed.
- Technical writing/reviewing to support production operations including, SOPs, qualification protocols, and batch records.
- Collect data for process qualification and implementation.
- Owning or supporting investigations related to material transfer, API production, drug substance formulation, drug product filling, inspection, and packaging.
- Support process optimization, development of new processes, and introduction of new technologies.
- Lead equipment qualifications and improvement projects. Support the execution of process validations.
- Responsible for all production instrumentation: IQ/OQ/PQ, owning equipment protocols/SOPs, coordinating PMs/calibration/requalification, maintaining inventory of spare parts, coordinating repairs, making minor repairs in-house.
- Provide guidance, support, training, and knowledge to Production team.
Expanded Responsibilities:
- Take a leadership role in managing multiple projects.
- Work with other employees on the Production and Quality teams.
- Coordinate internal resources and third parties.
- Supervise work of contractors.
- Create/maintain comprehensive project documentation. Work with Quality Unit to ensure readiness for inspections.
- Ensure that all activities are in compliance with GMP, FDA/NRC/EPA regulations, and Orano Med Policies.
- Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
- Support cross-functional teams to address all site-related activities, such as urgent events that regulations, and Orano Med Policies.
- Capable of being trained in production of API and aseptic final drug product. Willing to fill in on production team.
- Support cross-functional teams to address all site-related activities, such as urgent events that require technical expertise.
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
All candidates must meet the following minimum requirements to be considered for this opportunity. Candidates who exceed minimum qualifications may be considered for a higher-level position.
Qualifications:
- Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Sciences, Biology, or Chemistry.
- 3 years experience in a process support or development role in GMP manufacturing and/or QA/QC.
- Previous experience with qualifying instruments and processes in a new manufacturing facility.
- Understanding of manufacturing processes in pharma, GMP, quality and regulatory aspects.
- Proficient in technical writing.
- At ease with following detailed SOPs and completing extensive detailed documentation (e.g., batch records) and patiently revising documentation following QA review.
- Attendance of production up to 50%. Typical production shift will be approximately: 3:00 PM to 12:00 AM. Ability to work overtime, weekends, and off shifts, as needed.
- Knowledgeable on PPE: safety glasses/goggles, hair net, mask, gloves, appropriate shoes, and scrubs under a lab coat or Tyvek suit.
- Ability to safely lift 50 pounds.
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.
Orano Med
Orano Med is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the production of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative radioligand therapies which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells. With a solid portfolio of molecules in development capable of targeting various forms of cancer, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular for patients with currently unmet medical needs.
Find out more about Orano Med
Find out more about Orano Med
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