Job Description
Purpose:
Our Engineers play a vital role in ensuring the continuous operation and improvement of internal and external manufacturing processes.
We offer a diverse range of opportunities across various areas, including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
The External Manufacturing (Ex M) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position.
This person will work with External Partners to achieve business goals and establish a common culture that benefits our company, partners, and patients.
Responsibilities:
Tech Transfer and Commercial Production Support:
* Work with External Partners to execute technology transfers and commercial production of Biological Drug Substance at External Partner sites.
* Provide manufacturing process support to resolve commercial production issues.
Technical Activities:
* Responsible for technical activities related to commercial manufacturing processes at External Partner sites, including authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
* Author and/or review required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
On-Site Coverage:
* Provide on-site coverage at External Partner sites in support of Commercial and/or Technology Transfer Person-In-Plant activities.
Standardized Work and Compliance:
* Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
* Ensure that External Partners are inspection ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
Best Practices and Business Process Strategies:
* Responsible for participation in creating, sharing, and adopting best practices and business process strategies.
Qualifications:
Bachelors degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
Travel will be a requirement of this position at approximately 25%.
Strong communication in English and teamwork skills.
Preferred Experience and Skills:
* Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
* Demonstrated ability to independently manage projects/work to schedule/deadlines.
* Statistics experience (including Proactive Process Analysis and Continuous Process Verification).
* Experience in deviation management and/or change control and/or equipment support, and/or project management.
Language: English.
Location: Primarily home-based, can be located anywhere in Europe.
Benefits: Work From Home.