Process Engineer - External Manufacturing LM (m/w/d)

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)
• Travel will be a requirement of this position at approximately 25%

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.