Responsibilities
- Lead the Engineering Testing & laboratory team (ETAG) at AbbVie Ludwigshafen Device & Combination Product Development.
- Planning, coordination and execution of Engineering Confidence- and Design Verification Testing for Parenteralia / Pharmaceutical Application Systems (Combination Products) activities including functional performance testing of Combination Products and other studies where functional performance testing might be required.
- Proven leadership track record that includes the ability to influence and negotiate internally and externally as a part of global teams.
- Represents ETAG as single point of contact for assigned projects in local and global teams.
- Establishes and applies phase appropriate development & testing concepts for assigned projects in a resource responsible manner.
- Promotes harmonized development strategies across projects and sites.
- Drive test method development incorporating relevant standards requirements such as ISOs and/or Pharmacopeia and relevant AbbVie internal and/or external interfaces (regarding method comparability, applicable specifications, requirements for commercial process for In Process Controls and/or release tests).
- Validation of test methods for performance testing of Combination Products.
- Method Transfers and/or Co-Validation to relevant internal or external interfaces.
- Lead Non-conformity Investigations / Issue Resolutions.
- Provide general framework and guarantee documentation according to Good Manufacturing Practices (GMP) and Design Control applicable standards.
- Support compiling and verifying content for regulatory submission reports and providing relevant data in time.
- Define and establish Design Verification Processes.
- Exchange and align, where appropriate, cross-functional.
- Lead through and participate in initiatives for process improvements intra- and inter departmental.
- Guarantee GMP compliant framework regarding infrastructure such as Standard Operations Processes (SOPs) for the overall Quality System, training requirements and Instrument Qualification.
- Close exchange with different program leads and -interfaces at early- and late-stage Design Control process steps.
- Member in global Design and Development Teams and participation in Design Reviews as Design Verification Subject Matter Expert.
- Representative within internal and authorities inspections for the areas of responsibility.
- Demonstrate creative 'out of the box' thinking to solve difficult technical problems and champion new technologies to achieve project goals
Requirements
- Proven leadership track record that includes the ability to influence and negotiate internally and externally as a part of global teams.
- Ability to lead the Engineering Testing & laboratory team (ETAG).
- Experience in planning, coordination and execution of Engineering Confidence- and Design Verification Testing.
- Knowledge of Good Manufacturing Practices (GMP) and Design Control applicable standards.
- Experience in test method development, validation, and transfer aligned with ISOs, Pharmacopeia, and regulatory requirements.
- Ability to act as single point of contact for assigned projects in local and global teams.
- Experience participating in Design Reviews as a Design Verification Subject Matter Expert.
- Demonstrated ability to lead non-conformity investigations and issue resolutions.
- Experience ensuring GMP compliance including SOPs, training, and instrument qualification.
- Ability to support regulatory submissions with accurate and timely data.
Nice to Have
- Self-motivated and communicative person who thrives on solving complex problems.
- Excitement about tackling tough health challenges.
- Creative 'out of the box' thinking to solve difficult technical problems.
- Championing new technologies to achieve project goals.
Additional Information
- Role is based in Ludwigshafen, Germany.
- Position involves close collaboration with global teams.
- Candidate must be able to represent areas of responsibility during internal and regulatory inspections.
- Emphasis on process improvement initiatives within and across departments.
- Focus on robust device development enabling delivery of innovative medicines.
