For our customer located in Zurich/Switzerland we are currently looking for a: Process Packaging Engineer (Operations Lead)(m/f/d)
- Location: CH-Zurich / remote
- Branch: Pharma
- Duration: asap – 21.01.2025
- Travel: 15%
Tasks & Responsibilities
- Establish Packaging (technical) KPI’s in EST forumto ensure consistent, reproducible quality products are supplied to our patients
- Ensuring all Takeda PTRB, global core values and Takedisms are upheld in every task
- Author, review, approve regulatory and technical documentation, including but not limited to CMC, SOPs, Validation Master Plans and Technical Reports.
- Author, review,& approve eQMS documents including change controls, deviations, investigations, and CAPA’s.
- Insure automation readiness (DD&T)
- Foster, build and maintain strong relationships with key internal and external stakeholders
- Must be able to function independently in providingsound solutions to complex technical challenges.
- This role is will manage CMO activities including all the documentation requirements of Packaging operations
- Knowledge of cGMP documentation requirements a must
- Knowledge and experienced use of trackwise a must
- Knowledge of developing and experience in qualifying packaging components on packaging equipment a must
- Management (development, review and approval of) new and modifications to technical profile drawings and purchasing/release specifications a must
- Ability to multi task and achieve tactical deliverables with little to no supervision, while understanding strategic impact training.
- Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations.
Must Haves
- Bachelor’s Degree in an engineering related field; Packaging Engineers
- Minimum 5 years pharmaceutical experience (or equivalent)
- Knowledge of electronic documentation systems (MUST: Trackwise)
- Strong knowledge of cGMP documentation requirements
- Strong technical, interpersonal, communication and leadership skills.
- CORE ELEMENTS RELATED TO THIS ROLE (Describe what is critical and/or what differentiates this role).
- Requires technical degree (ideally one in Packaging Engineering)
- Minimum 4 to 8 years pharmaceutical GMP experience
- Change control and documentation systems management knowledge a requirement (Trackwise, Veeva, SAP, or equivalents).
- Demonstrated ability to simultaneously manage multiple projects of variable complexity.
- Strong team work ethic, excellent oral and written communication and presentation skills.
- Digital Data, Artificial Intelligence/Automated Visual Inspection systems capable
- Knowledge of serialization global requirements and execution
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- Normally requires an advanced degree in a scientific/technical discipline with 4-8years experience.
- Experienced collaboration with highly technical cross-functional global teams.
- Advanced knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and DEA Regulations is preferred. JP, SFDA, etc. is a PLUS
- Solid organization, problem solving, project-management, decision-making, judgment and team-oriented skills are essential.
- Demonstrated ability to simultaneously manage multiple projects of variable complexity.
- High change agility with ability to see the strategic while managing the tactical elements of global pharmaceutical product packaging.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.