Senior Packaging Engineer

SimplyVision GmbH; Zürich; Hybrid; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

SimplyVision GmbH in Zurich is seeking a Packaging Engineer (m/f/x) to cover maternity leave. You will manage cGMP packaging activities for Biologics, Synthetic and Oncology products, coordinating with CMOs and internal teams.

The role requires TrackWise and regulatory documentation experience, strong communication, and the ability to drive changes across EU/ROW and US markets, while ensuring right-first-time compliance.

Qualifikationen

• Bachelor’s degree in engineering; Packaging Engineers preferred.
• Experience in pharmaceutical packaging and cGMP documentation.
• Proven ability to manage multiple tasks with minimal supervision.
• Strong communication, leadership and cross-functional collaboration skills.
• Experience with TrackWise and electronic change controls.

Aufgaben

• Manage cGMP packaging activities for Biologics, Synthetic and Oncology products.
• Coordinate changes across EU/ROW and global CMOs/partners.
• Develop and approve packaging specifications and process validation plans.
• Maintain documentation systems (Veeva/TrackWise) and CAPA workflows.
• Collaborate with QA, Manufacturing, Regulatory and supplier teams to ensure on-time delivery.

Kenntnisse

cGMP knowledge

TrackWise

Packaging engineering

Cross-functional collaboration

Documentation experience

Ausbildung

Bachelor's Degree in engineering

Tools

Veeva

Jobbeschreibung

For our customer located in Zurich (CH) we are currently looking for a: Packaging Engineer (m/f/x)

General Information:

• Branch: Pharma
• Working Model: hybrid (min. 8 days/month onsite, remaining days can be done remotely)
• Duration: 01.11.26 – 31.12.27 (maternity leave cover)

Tasks & Responsibilities

This role is will manage CMO activities including all the documentation requirements of Packaging operations

• Scope of work includes all commercial products in the Biologics, Synthetic and Oncology portfolio, packaged within the internal Packaging Network and approved contract manufacturing organizations (CMO’s) throughout our client’s global footprint with focus on EU/ROW.
• Candidate will function EU based above site Packaging Engineer SME. Is responsible, as an individual contributor to managing ALL impacted changes for the group, in US, EU and Rest of World markets GSQ Portfoilio. This role is to support external CMO Packaging Engineering but may include projects/product supplied both from internal and external CMO operations.
• 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
• Managing quality documentation systems such as Veeva or Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must)
• Interacts closely and builds strong relationships with internal cross functional team members as well as external technical experts at CMOs
• Manages multiple tasks with focus on purpose and impact to strategy/business
• Delivers on time, in full and right first time (compliance in highly regulated environment)
• 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)

Must Haves

• Bachelor’s Degree in an engineering related field; Packaging Engineers preferred
• 5 years pharmaceutical experience (or equivalent)
• Knowledge and experienced use of trackwise a must
• Knowledge of developing and experience in qualifying packaging components on packaging equipment a must
• Strong knowledge of cGMP documentation requirements
• Strong technical, interpersonal, communication and leadership skills.
• Knowledge of electronic documentation systems (MUST: Trackwise)
• Demonstrated abilities to manage and collaborate across internal stakeholders such as packaging colleagues, quality…
• Demonstrated strength in cross boundary communication, influencing others, working in cross-functional teams
• Demonstrated organizational skills including project management
• Must be a team player who can manage multiple tasks, a dynamic environment with a positive, outgoing spirit
• Change agility and resilience; ability to work across time zones in matrix organization
• Builds relationships based on integrity, fairness, honesty and perseverance