Client Description
For one of our clients, a leading global biotechnology company located in the greater Lucerne area, we are currently seeking a Process Engineer (Associate Specialist Downstream Operations) (m/f/d) to join a state-of-the-art biologics manufacturing facility. This innovative manufacturing site specializes in the development and production of biologic drug substances for clinical programs and technology innovation initiatives. The organization is committed to delivering high-quality medicines through advanced manufacturing technologies, operational excellence, and a strong culture of quality and compliance.
About the Role
We are looking for a motivated Process Engineer (Associate Specialist Downstream Operations) (m/f/d) to support downstream manufacturing activities related to the implementation and GMP manufacturing of early-phase clinical therapies. In this role, you will be responsible for supporting purification and manufacturing processes within a GMP-regulated biotech environment. You will work closely with cross-functional teams to execute manufacturing campaigns, troubleshoot technical issues, support process improvements, and ensure compliance with quality and safety standards.
Responsibilities
- Act as the primary point of contact for import, export, and distribution-related activities across the site.
- Coordinate end-to-end import and export processes, including customs instructions, broker communication, and shipment tracking.
- Review customs declarations and maintain accurate trade and logistics records.
- Prepare export and shipping documentation, including proforma invoices, packing lists, dangerous goods declarations, and certificates of origin.
- Ensure all required import/export permits, licenses, and regulatory documentation are obtained and maintained.
- Coordinate and oversee temperature-controlled air and ground transportation for domestic and international shipments.
- Process customs declarations using EDEC and Expovit systems.
- Monitor logistics activities to ensure compliance with Global Trade Compliance standards and internal procedures.
- Prepare, maintain, and analyze operational reports, statistics, and key performance indicators.
- Ensure compliance with GMP, GDP, EHS, and trade compliance requirements within the area of responsibility.
- Support the creation, review, and approval of GMP-relevant documentation.
- Utilize regulated systems such as Veeva, MEDS, and other GxP-compliant platforms to support quality and compliance activities.
- Collaborate closely with internal stakeholders, logistics providers, customs authorities, and external partners to ensure efficient and compliant movement of goods.
- Contribute to process improvements and operational excellence initiatives within import/export and distribution operations.
Your Profile
We are seeking candidates who possess the following qualifications:
- Several years of experience in Import/Export, Customs Operations, International Trade, Supply Chain, or Logistics.
- Experience working within pharmaceutical, biotechnology, healthcare, or other highly regulated industries is preferred.
- Knowledge of international trade regulations, customs procedures, and import/export compliance requirements.
- Experience with GMP and GDP regulations is considered a strong advantage.
- Good knowledge of Microsoft Office applications; SAP experience is an advantage.
- Strong organizational skills with excellent attention to detail.
- Ability to work independently, prioritize workload, and manage multiple tasks simultaneously.
- Strong problem-solving skills with a proactive and solution-oriented mindset.
- Excellent communication and stakeholder management skills.
- Professional communication skills in German and English, both written and spoken.
Preferred Qualifications
- Experience coordinating temperature-controlled pharmaceutical shipments.
- Knowledge of customs declaration systems such as EDEC and Expovit.
- Experience preparing dangerous goods documentation and international shipping documents.
- Familiarity with Trade Compliance standards and global logistics operations.
- Experience working with regulated systems such as Veeva, MEDS, or similar GxP-compliant platforms.
- Exposure to pharmaceutical distribution and supply chain operations.
Additional Information
- Location: Lucerne Area
- Contract Duration: 12-month contract position, with the possibility of extension.
- Employment Type: Temporary Staffing
- Work Model: 100% Onsite
- Working Hours: 40 hours per week
Apply online using the form below. Only applications matching the job profile will be considered.
Work locationLucerne, Lucerne, Switzerland