Packaging Engineer (Pharma)
Experis is the global leader in professional resourcing and project-based workforce solutions.
On behalf of our client a global Pharmaceutical client based in Zurich we are looking for a Pacakaging Engineer.
The Packaging Engineer Contractor 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
* Support team in substantiating and qualifying alternate component substrates, suppliers, and processes to mitigate risk of supply
* the development (input), launch, life cycle management and continuous improvement of primary and/or,
* Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling Operations
* Manage implementation of platform (harmonization / standardization) components
* Manage bill of materials, etc.
* Candidate will facilitate template inclusion of regulatory (serialization)and global corporate standard labeling requirements (i.e. authentication)
Scope of work includes all commercial products in the Oncology, Small Molecule portfolio, packaged within the internal Packaging Network and approved contract manufacturing organizations (CMO's) throughout global footprint.
Technical/Functional (Line) Expertise
- cGMP SME in packaging
- Technical specification, profile drawing development, review and approval
- Packaging Process Validation
- Specification development, review, approval and implementation
- Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must)
- Interaction Must be a team player who can manage multiple tasks, a dynamic environment with a positive, outgoing spirit
- Change agility and resilience
- Builds relationships based on integrity, fairness, honesty and perseverance
- Interacts closely and builds strong relationships with internal cross functional team members:
- Manages multiple tasks with focus on purpose and impact to strategy
- Delivers on time, in full and right first time
- Demonstrated strength in cross boundary communication, influencing others, working in cross-functional teams
- Demonstrated organizational skills including project management
- Bachelor's Degree in an engineering related field; Packaging Engineers preferred
- 5 years pharmaceutical experience (or equivalent)
- Strong knowledge of cGMP documentation requirements
- Strong technical, interpersonal, communication and leadership skills.
- Knowledge of electronic documentation systems (MUST: Trackwise)
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23