We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Recruitment activities are focused on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the highest demands on quality, ethics and discretion.

For our client, the company CSL Behring, we are looking for a

Engineering Project Manager (m/f/d)

Description

CSL Behring AG in Bern specializes in the manufacture of drugs for the treatment of immune deficiencies and immune dysfunction, as well as drugs for rhesus prophylaxis and albumin solutions for shock and burn victims. CSL Behring AG's production facilities are licensed by the Swiss health authorities and the US FDA. Every year, therapeutically important proteins are isolated from over six million liters of human plasma in accordance with the strictest safety and quality standards and processed into medicines. The products of CSL Behring AG are distributed worldwide.

The Technical Lead supports the CAPEX Project Manager by taking the lead in technical coordination activities across cross-functional teams. This role involves ensuring that all technical deliverables are designed, written, reviewed, approved and executed in accordance with internal engineering standards and regulatory expectations. The candidate acts as the key technical contact point for all involved stakeholders and external partners, contributing to the successful and compliant execution of engineering and qualification projects in GMP-regulated environments.

Working hours

Standard: 41h

Where prescribed and required, wear protective equipment consistently and replace when defective.

Eliminating hazards and risks immediately where possible, otherwise report them to supervisor immediately.

Conduct and lead risk assessments, including FMEA and design reviews.

Support Annex 1 related projects and contribute to ensuring compliance of manufacturing systems with GMP and internal standards.

Drive the technical development of solutions to ensure process and equipment compliance.

Author and review project related documents including URS, URB, and project descriptions.

Review and align external supplier deliverables with internal engineering and quality standards.

Serve as the technical point of contact between departments including Sterility Assurance (SA), Quality Assurance (QA), Production (PRO), Process Engineering (PE), and Project Delivery (PD).

Lead and participate in project meetings, ensuring technical topics are clarified, documented, and followed up.

Represent the technical function in cross - functional workshops and ensure alignment on technical decisions.

Provide technical support during plant shutdown periods, including preparation, execution, and post - shutdown evaluations.

Preferably on-site presence for coordination, with up to 40% flexibility for home office.

Act as a technical liaison and support contact for operators.

Support training sessions and information briefings for shop floor personnel.

Bachelor’s or master’s degree in engineering (Mechanical, Electrical, Process, Chemical, or equivalent).

Fluent in English (written and spoken) & German language skills are necessary

Minimum 5 years of experience in technical project execution within GMP-regulated environments (pharmaceutical, biotech, or life sciences).

Solid understanding of cGMP, EU Annex 1, and engineering documentation.

Proven experience in FMEA, technical troubleshooting, and interfacing with multiple departments.

Strong communication and organizational skills, with the ability to proactively drive tasks and deliverables.

Are you interested?

Then Mr. André Amstad looks forward to receiving your complete application documents (CV, certificates and training certificates). We look forward to hearing from you.

We look forward to hearing from you.