Senior Pharma Process Engineer, Aseptic Fill & Finish

Key Facts

• Start date: ASAP
• Initial duration: 6 months
• Extension: Depending on project requirements
• Workload: 80–100%
• On-site presence: 4–5 days per week
• Remote work: No fixed home-office day possible during the current project phase
• Work model: Temporary project assignment
• Language: Fluent English required, German is an advantage

Your Responsibilities

• Support the implementation, qualification and finalisation of a new pharmaceutical production line
• Work hands-on with the equipment during the current project phase
• Establish and optimise processes within sterile manufacturing
• Monitor manufacturing activities, including preparation, filling, in-process controls and documentation
• Create and revise SOPs and electronic batch records within the MES
• Investigate and process deviations and change requests
• Continuously improve validated manufacturing processes and workflows
• Support internal and external audits as well as regulatory inspections
• Collaborate closely with Manufacturing, Engineering, Quality and other project stakeholders

Your Profile

• University degree or equivalent higher education in Engineering, Pharmaceutical Technology, Chemistry, Biology or a related field
• Several years of experience in pharmaceutical process engineering within a GMP-regulated environment
• Ideally, experience in sterile manufacturing and aseptic Fill & Finish
• Experience in the implementation, qualification and optimisation of pharmaceutical production equipment
• Strong technical understanding and a willingness to work directly with the equipment
• Experience with SOPs, batch records or MES, deviations and change requests
• Independent, pragmatic and solution-oriented working style
• Strong hands-on mentality and the ability to work effectively in a dynamic environment
• Fluent English is essential
• German would be an advantage but is not required
• Willingness to work on-site 4–5 days per week

What You Can Expect

• A technically challenging project within a sterile pharmaceutical manufacturing environment
• A key role in the finalisation and operational stabilisation of a new production line
• The opportunity to contribute your expertise directly to equipment and manufacturing processes
• Collaboration within an eight-person core team and a wider department of approximately 35 employees
• A dynamic working environment with short decision-making paths and a strong hands-on culture