Über
Do not pass up this chance, apply quickly if your experience and skills match what is in the following description.
We are currently seeking a
Manufacturing Support Scientist/Engineer
to join a high-performing biologics manufacturing team, supporting
New Product Introduction (NPI)
activities in a fast-paced GMP environment.
This is an exciting opportunity to play a key role in bringing new biologics products into commercial manufacturing, working cross-functionally to ensure robust, efficient, and compliant processes.
Collaborate with cross-functional teams (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain) to support
new product introductions, process improvements, and change initiatives
Support
risk assessments
to ensure appropriate controls are in place for manufacturing readiness
Contribute to
technology transfer activities , including preparation of documentation for development, engineering, and PPQ batches
Lead and support
change controls, CAPAs, deviations, and investigations
Develop
process impact assessments
and support product changeover strategies
Act as a
manufacturing representative
to ensure end-user requirements are captured
Drive
process improvement projects
and support implementation through to completion
Provide
SME input
into process optimization, procedures, and documentation updates
Support
audit readiness
(internal and external)
Deliver
training and knowledge transfer
to operations teams
Support the introduction of
new raw materials, consumables, and technologies
(e.g. single-use systems)
Promote a
Right-First-Time culture
and apply
lean manufacturing principles
Approve GMP documentation including
SOPs and electronic batch records
Support sustaining operations as needed to ensure continuity of supply
Qualifications & Experience
Bachelor’s or Master’s degree (or near completion) in
Science, Engineering, or a related discipline
Strong understanding of
GMP biologics manufacturing processes and equipment
Experience supporting
technical investigations and deviation closeout xcfaprz
Working knowledge of systems such as
DeltaV, MES (e.g. Syncade), and SAP
Demonstrated
problem-solving, project management, and organizational skills
Excellent
communication and stakeholder engagement
abilities
Experience in
lean manufacturing / operational excellence
is highly desirable
Ability to thrive in a
collaborative, fast-paced environment
with changing priorities
Strong team player with the ability to
influence across functions
Proactive mindset with a focus on
continuous improvement
High attention to detail with a commitment to
quality and compliance
Confidence in working across technical and operational teams
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Sprachkenntnisse
- English
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