Process Engineer.

For our client company in Luzern, we are currently looking for a Process Engineer, a highly motivated individual to fill an open position to support drug substance tech transfer and commercial manufacture within their External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives. Our client's team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the large molecule line of business at our company.

Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate. With their extensive range of facilities and environments, the Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.

General information:

Starting Date: ASAP or 02/01/2025

Contract: 1-year temporary contract via Randstad, with the possibility of extension

Work Location: Position can be performed 100% remotely within Switzerland

Travel: This position requires approximately 25% international travel to support business needs; candidates should be prepared for frequent trips abroad.

Responsibilities include:

• 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

Education Minimum Requirement:

• Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field

Required Experience and Skills:

• Minimum of 5 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, 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
• Proven team building skills
• Excellent command of English (both written and oral), German or Italian a plus

Preferred Experience and Skills:

• Experience in biologics manufacturing
• Experience with the manufacturing of ADCs
• Project management experience
• Experience in deviation management and/or change control and/or equipment support, and/or project management.
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.