Expert External Manufacturing Large Molecule DS Tech Ops - Engineering (m/f/d)
Responsibilities
- Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients
- Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers
- Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings
- Responsible for technical activities for the commercial manufacturing process at the external partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events
- Develops solutions to complex technical issues that require a high degree of ingenuity, creativity and innovation. Requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products
- Provide on-site coverage at external partner in support of commercial and / or tech transfer person in plant activities
- 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
- Responsible for participation in creating, sharing, and adopting best practices and business process strategies
Profile
- Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field
- Post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Oprations, Technology or Engineering
- Ability to work independently as well as excellent organizational skills / Strong professional and interpersonal communication skills
- Must be able to multi-task and work within tight deadlines
- Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation
- Excellent command of English (both written and oral)
- Travel will be a requirement of this position at approximately 20%
- Experience in biologics drug substance manufacturing / Experience in deviation management and/or change control and/or equipment support
- Project management experience / Proven team building skills
- Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.
Benefits
- International Pharmaceutical organisation
- Remote working possibility
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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