- FR
Investigations Specialist - Biotech (F/M)
Investigations Specialist - Biotech (F/M)
About the role
To join our Life Sciences team in Lausanne, we are looking for an Investigations Specialist (F/M) in the biotechnology sector.
The purpose of this role is to manage deviations occurring in the different manufacturing suites (USP and DSP), for the different products within quality system (i.e. Trackwise) in a timely manner.
- Perform evaluations related to impact on concerned equipment/product/material with the support of relevant experts,
- Perform root cause investigations using Six Sigma methodologies (DMAIC, Ishikawa diagram, 5M, contradiction matrix, etc.), including ability to collect and analyze data in the different automated systems and on-the-floor (regular GEMBA),
- Identify and implement relevant corrective and preventive actions (CAPA), including business case and planning preparation with relevant stakeholders,
- Write investigation and impact assessment reports in a comprehensive and scientific format,
- Present report-out and/or escalate blocking points to line Manager,
- Monitor and control internal deviations and CAPA KPI in concertation with line Manager,
- Depending on deviation complexity, lead cross-functional investigation team including workshop or brainstorming sessions.
Your profile
- Bachelor/Master in Engineering field (chemical, biotechnology) or equivalent,
- 3-5 years of experience within a biotech/pharmaceutical GMP manufacturing environment,
- Strong knowledge and interest in biotechnological processes (USP and/or DSP),
- Good knowledge of cGMP and associated regulations,
- Ability to describe complex technical processes or problems into simplified and concise reports,
- Ability and appetence for working cross-functionally, interacting daily with various stakeholders (Manufacturing personnel on the floor, MSAT, QA, QC, Engineering, EHS, etc.) in a team-based culture,
- Fluent in French and English.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
Investigations Specialist - Biotech
Location : Vaud
Start date: Asap
Workload: 100%, on-site
To join our Life Sciences team in Vaud, we are looking for an Investigations Specialist. You will manage and resolve manufacturing deviations in the Downstream Processing (DSP) area, ensuring timely and compliant investigations within the quality system.
The project:
- Lead deviation investigations using Six Sigma methods (DMAIC, Ishikawa, 5M, etc.).
- Evaluate equipment, product, and material impacts with expert support.
- Identify root causes and define corrective/preventive actions (CAPA).
- Prepare and present investigation reports and action plans.
- Track key performance indicators (deviations and CAPA).
- Facilitate cross-functional workshops when needed.
Occupational Safety Engineer
Locations : Geneva
Start date : Asap
Staffing: 100%, on site
To join our teams near Geneva, we are recruiting an Occupational Health and Safety Engineer.
The project :
- Implement and monitor health and safety policy across several departments.
- Manage the health and safety management system (risk analysis, audits, training, reporting, action plans).
- Contribute your safety expertise to construction and renovation projects.
- Ensure fire safety compliance and coordinate relations with authorities and partners (inspectorate, OCIRT, SUVA, etc.).
- Participate in the continuous improvement of QSSE management systems.
Industrialization & Environment Project Manager
Locations : Geneva
Start date : Asap
Staffing: 100%, on site
To join our teams in Geneva, we are recruiting an Industrialization & Environment Project Manager whose main mission will be to guarantee legal compliance and the reduction of environmental impacts in the context of industrial equipment acquisition projects.
The project :
- Manage the continuous improvement of equipment specifications, integrating environmental and energy requirements.
- Define objectives and guide the sustainability strategy for industrial equipment acquisition projects at production sites.
- Promote and integrate eco-design principles into the development of new equipment.
- On priority projects, ensure the management of environmental objectives, from the definition of specifications to industrial qualification, by mobilizing all stakeholders.
- Evaluate technical concepts, validate proposed solutions and contribute to decision-making.
- Organize the capitalization and valorization of environmental data in dedicated IT tools.
- Participate in internal skills networks and cross-functional groups.
- Communicate proactively and clearly with all your contacts.
Automation technician
To join our teams near Freiburg, we are looking for an Automation Engineer with mastery of Beckhoff, Siemens, Rockwell.
The project :
- Develop, test and validate software enhancements for CNC machine tools.
- Optimize software performance and stay at the cutting edge of technology.
- Collaborate with other engineers to integrate software solutions.
- Maintain existing software and provide technical support to users.
Project Manager - Equipment Design
We are looking for a proactive and detail-oriented Project Manager in Equipment Design to lead the development, design, and implementation of process equipment within a regulated environment. You will oversee technical design activities from concept to qualification, ensuring compliance with engineering standards, project timelines, and GMP requirements.
Your role:
- Lead equipment design projects from feasibility through to commissioning and qualification.
- Coordinate mechanical, automation, and process design activities with internal and external stakeholders.
- Develop and review technical specifications, design documentation, and FAT/SAT protocols.
- Manage supplier relationships, including technical alignment, design reviews, and project follow-up.
- Ensure budget and schedule control across all project phases.
- Oversee change management and risk assessment related to equipment design and modifications.
- Support CQV teams during qualification phases and participate in design improvement workshops.
- Guarantee compliance with GMP, safety, and quality standards for all equipment.
Investigations Specialist - Biotech (F/M)
About the role
To join our Life Sciences team in Lausanne, we are looking for an Investigations Specialist (F/M) in the biotechnology sector.
The purpose of this role is to manage deviations occurring in the different manufacturing suites (USP and DSP), for the different products within quality system (i.e. Trackwise) in a timely manner.
- Perform evaluations related to impact on concerned equipment/product/material with the support of relevant experts,
- Perform root cause investigations using Six Sigma methodologies (DMAIC, Ishikawa diagram, 5M, contradiction matrix, etc.), including ability to collect and analyze data in the different automated systems and on-the-floor (regular GEMBA),
- Identify and implement relevant corrective and preventive actions (CAPA), including business case and planning preparation with relevant stakeholders,
- Write investigation and impact assessment reports in a comprehensive and scientific format,
- Present report-out and/or escalate blocking points to line Manager,
- Monitor and control internal deviations and CAPA KPI in concertation with line Manager,
- Depending on deviation complexity, lead cross-functional investigation team including workshop or brainstorming sessions.
Your profile
- Bachelor/Master in Engineering field (chemical, biotechnology) or equivalent,
- 3-5 years of experience within a biotech/pharmaceutical GMP manufacturing environment,
- Strong knowledge and interest in biotechnological processes (USP and/or DSP),
- Good knowledge of cGMP and associated regulations,
- Ability to describe complex technical processes or problems into simplified and concise reports,
- Ability and appetence for working cross-functionally, interacting daily with various stakeholders (Manufacturing personnel on the floor, MSAT, QA, QC, Engineering, EHS, etc.) in a team-based culture,
- Fluent in French and English.
About Antaes
Founded in 2007, Antaes is a Swiss management and technology consulting company ranked among the top 15 consulting firms in Switzerland. We employ over 300 experienced consultants who share our passion.
With offices in Switzerland, Singapore, Hong Kong and France, we support our Swiss and international customers at clients in the following areas:
- Organization and transformation consulting
- Industrial Engineering
- Information Systems Management
By joining our teams you will discover :
- A dynamic team in a start-up spirit
- Human support and career development monitoring
- Challenges to help develop your network
- Events: team building, meet-up, workshop, Winter Event ...
-
An @HappyAtWork certified company with a committed CSR policy (Ecovadis2023 Gold Medal)
