Process Engineer II

CK QLS is looking for a Specialist Manufacturing Technologies & Engineering to join a global pharmaceutical company based in Lucerne for a duration of 12 months with an option for an extension.

As a member of the Manufacturing Technologies & Engineering group, the successful candidate will be responsible for providing assistance and support to the MES (Manufacturing Execution System) Implementation Project Manager and Team in the successful implementation of the MES system. The P2 Support will contribute to the planning, coordination, and execution of the project, ensuring its alignment with organizational goals and objectives.

Responsibilities for this position will be tailored to the qualifications of the candidate and may include, but are not limited to:

• Collaborate with the PAS-X Implementation Project Manager to develop and maintain project plans, schedules.
• Assist in the coordination and management of project activities, including vendor coordination, training and workshop organization and task tracking.
• Facilitate communication among project stakeholders, ensuring that all relevant parties are informed of project progress, issues, and risks.
• Prepare and deliver project-related documentation, such as progress reports, meeting minutes, and presentations.
• Provide support during the GMBR design, testing, training, and eBR go-live phases of the PAS-X implementation project.
• Collaborate with cross-functional teams to ensure the successful integration of the MES system with other business processes and systems.
• Supporting capital requests and sourcing activities.
• Qualification of devices and equipment.
• Authoring standard operating procedures.
• Providing support for the manufacturing of clinical supply drug substance, including resupply activities.
• Operating equipment according to batch records, sampling plans, and standard operating procedures.
• Collaborating with Facility Management and internal team members to ensure GMP compliance through routine monitoring, calibration, maintenance, and certifications of responsible equipment devices.

A typical workday would start between 7 and 8 am. Our site follows a tier structured model where team-level meetings (Tier 1) occur 1-2 times per week, among other tiers. Daily work can be planned and conducted independently, including qualification work and project meetings. Each team member has individual projects, but teamwork and collaboration are important for discussing project approaches, supporting each other, and driving improvements. While there is the possibility for working remotely, remote work is limited due to the projects and implementations led by the MT&E team.

What skills you will need: To excel in this role, the ideal candidate will likely possess the following:

• A degree qualification in a relevant field (Science/Technical). An Advanced Degree (BSc or MSc) is desirable.
• At least 2 years of experience working in a relevant academic or industry field.
• Knowledge of manufacturing processes and systems, particularly MES concepts and tools, such as PAS-X, Syncade, COMET etc. is desirable.
• Previous experience in supporting or assisting in project management activities, preferably in an MES implementation or related field.
• Proficiency in relevant software applications, such as Microsoft Power Project and project management tools.
• Understanding of general principles of equipment qualification.
• Experience in cGMP in a sterile, vaccine, bulk, or finished goods pharmaceutical environment.
• Proficient verbal and written communication skills in English (B2). Proficiency in German (B1) is desirable. 
• Ability to work effectively as part of a team and independently.

Apply:

Please could you send any correspondence in English. Please quote job reference 101372 in all correspondence.