Process Support Engineer / Process Development Engineer – Uppsala / Sweden
We are looking for a person with team lead experience, hands-on experience from late-stage process development, and technical transfer to GMP manufacturing and validation in the field of oral solid dosages.
The project will be initiated in Uppsala, Sweden. Future scaling is planned for and international opportunities will be generated.Key Responsibilities
- Performs startup of manufacturing equipment through Process Qualification.
- Acts as a site lead coordinating customer activity with the product business group. Works autonomously within established procedures and practices
- Drives the adoption of new technology at the customer site. Works closely with customer to demonstrate and qualify processes through demos, on site evaluations, joint development programs and new tool qualifications.
- Serves as liaison between the customer and the Product Business Group for assigned projects, ensuring clear understanding of customer issues and delivery of applicable solutions.
- When necessary, works closely with customer to optimize tool performance to meet customer process and integration requirements.
- Checks and approves operational quality of system equipment. Operates the equipment and characterizes material processed on the equipment. Maintains written and electronic data as required by regulatory authorities.
- Ensures the correct revisions of procedures and schematics and creates methodologies and procedures as necessary. Participates in patent processes/discussions and documents IP as appropriate.
- Takes initiative to avoid and resolve customer problems. May initiate projects to improve system performance or reduce cost.
- Anticipates and responds to customer issues, including communicating with product business group to drive corrective actions. Participates in customer meetings and escalations. Instructs customers in the operation and maintenance of system.
Education and Experience
- Keeps field management and product group informed on customer perception of system performance. Follows all checklists and procedures, including safety.
- A solid background in chemistry / physics is desired. Bachelor's Degree minimum, Master's Degree or higher preferred
- The job will be partly customer facing and require good communication skills, project management experience as well as ability to design experiments and support the operators and equipment engineers to perform document and analyse results from experiment runs.
- Demonstrated expertise in operation of a pharmaceutical manufacturing equipment
- Experienced with the material characterization techniques commonly used in pharmaceutical development
- Experienced with handling of pharmaceutical ingredients in a GMP setting
- Demonstrated analytical ability to determine root cause of problems and identify innovative solutions
- Able to communicate effectively with customers in a dynamic environment, including communicating technical content in a clear manner; and negotiating with others to adopt a different point of view. Aptitude to work and communicate within a team and within a culturally diverse organization
- Flexibility to work overtime and in a cleanroom environment with personal protective equipment
- Limited travel (estimated 10 %) however, at times on short notice
- Languages: Swedish, English
- A solid financial package, including Stock Program (employee Purchase Stock Program, Car Allowance, Home office Allowance , a Performance Based Bonus and participation in a corporate pension plan.
- Extensive training in Applied's technology and equipment, in one of our Technology Centers
- Global Network of Expertise and the support of an established and financially successful multinational
- Opportunity to join early and to become the Expert in Europe in this field, creating chances for career advancement
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