Packaging Engineer Contractor

K-Recruiting Life Sciences; Zürich; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

K-Recruiting Life Sciences is seeking a Packaging Engineer SME to support CMO packaging operations in Zurich. The role emphasizes cGMP documentation, TrackWise change controls, and qualification of packaging components for biologics, synthetic, and oncology products.

This maternity cover position starts 02.11.2026 for 14 months with up to 8 days on-site per month. You will manage documentation templates and collaborate with global QA, labeling, and manufacturing teams.

Qualifikationen

• Bachelor’s degree in engineering or related field; Packaging engineers preferred.
• Strong knowledge of cGMP documentation requirements.
• Experience with TrackWise or similar electronic documentation systems.

Aufgaben

• Manage CMO packaging documentation and change controls; ensure compliance with cGMP.
• Lead qualification of packaging components and materials for multiple portfolios.
• Develop and review technical drawings and release specifications; support platform standardization.
• Coordinate with QA, regulatory, and manufacturing across global sites to mitigate risks.

Kenntnisse

cGMP documentation

TrackWise

Packaging qualification

Change control

CAPA

Cross-functional collaboration

Ausbildung

Bachelor’s degree in engineering (Packaging preferred)

Tools

TrackWise

Veeva

Jobbeschreibung

• This role is will manage CMO activities including all the documentation requirements of Packaging operations
• Knowledge of cGMP docuemntation 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 Biologics, Synthetic and Oncology portfolio, packaged within the internal packaging Network and approved contract manufacturing organizations (CMO’s) throughout 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.
• 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)

Qualification:

• Maternity Leave Cover (could be extended)
• 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.
• 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
• Knowledge of electronic documentation systems (ideally Trackwise)

Requirements:

Start: 02.11.2026

Duration: 14 months

Location: Zurich, Switzerland (maximum 8 days on-site per month)