Process Validation Subject Matter Expert
vor 1 Woche
We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through diagnostics, or develop and manufacture life-enhancing therapies.
We are more than 100,000 colleagues to offer an unmatched combination of innovative technologies, convenient purchasing processes and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
The brand new multi-purpose manufacturing and development site in Lengnau is designed for large scale biologics manufacturing and has high expansion potential.
After completion of the construction phase, our Lengnau site will offer highly flexible biomanufacturing technologies, from process development to large-scale production, including stainless steel equipment, in order to successfully meet the needs of our customers.
Location:
Lengnau
In this position, you will be responsible for the execution of Process Validation and ensure compliance to regulatory requirements and industry standards.
The role establishes and maintains Validation Master Plans, Validation Protocols, Reports and supportive risk assessments and is accountable of the validation strategy definition.
You will develop the scientific content relating to validation activities with an emphasis on risk-based, science-based approaches to Process Validation and to current Good Manufacturing Practices.
Your Responsibilities:
- Plan and perform validation studies for the Lengnau Site, currently for one dedicated bulk drug substance production line at a scale of 14,000 L bioreactor fedbatch processes including ancillary validation activities for recombinant protein manufacturing, Resin Lifetime Validation and Continuous Process Verification. The role will extent to additional suites of production.
- You will be responsible for the timely preparation of validation documentation, such as study protocols, sampling plans and generation of the validation reports.
- Manage the validation schedule and the coordination and execution of process validation activities including training of operations.
- Be a key contributor to issue resolution arising from validation activities in cooperation with Operations (e.g., deviation handling, change requests).
- Serve as the primary point of contact for our customers' requests on process validation.
- Support regulatory inspections by presenting validation strategies (per products) and related validation documents.
- Interact with other sites validation teams through the global team, participate to global validation strategy definition and implementation, ensuring aligned approaches and knowledge exchange management.
Your profile:
- Degree (Bachelor, Masters or higher) in Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent
- Proven experience (7+ years of experience preferred) in process validation preferably gained within on a Life Sciences / Pharma / Biotech Upstream/Downstream/ manufacturing facility.
- A documented trackrecord and handson knowledge in biotech or pharmaceutical manufacturing processes.
- Fundamental understanding of biopharmaceutical analytical methods.
- Proven experience in cGMP and GxP and regulations and guidelines related to process validation.
- Language skills: English (Fluent) and German (beneficial)
Our offer:
You can expect a varied job in a dynamic and international environment. A culture in which integrity, intensity, involvement and innovation are lived. A well-founded induction and task-specific training are a matter of course for us. You will define your future in our company - make your contribution to our joint success
Are you interested?
Each of our 100,000 outstanding individuals at Thermo Fisher Scientific has a very personal story. Join us and contribute to our unique mission.
Thermo Fisher Scientific is committed to equal opportunity as an employer and does not discriminate on the basis of ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability or legally protected status.
-
QA Validation Expert
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...
-
Process and Cleaning Validation SME
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant...
-
Process and Cleaning Validation SME
vor 3 Wochen
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant...
-
Process and Cleaning Validation SME
vor 3 Wochen
Lengnau BE, Bern, Schweiz ThermoFisher Scientific VollzeitJob Description When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.Process and Cleaning...
-
Process and Cleaning Validation SME
vor 1 Monat
Lengnau BE, Bern, Schweiz ThermoFisher Scientific VollzeitJob Description When you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.Process and Cleaning...
-
Dsp Scientist Process Development
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through...
-
Scientist in Analytics, Process Development
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Biologics Lengnau VollzeitThe brand new multi-purpose manufacturing and development site in Lengnau is designed for large scale biologics manufacturing and has high expansion potential. After completion of the construction phase, our Lengnau site will offer highly flexible biomanufacturing technologies, from process development to large-scale production, including stainless steel...
-
Director, Process Development
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitThe Director, Process Development manages a large team of scientists, supervisors and managers that are assigned to a more than one functional area and/or site. Responsible for overseeing the global alignment, strategic growth and continuous improvement of their department to align with long term strategy of the business unit and company. Accountable for the...
-
Manager Process Automation and Manufacturing
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitAre you ready to take your engineering career to the next level? Thermo Fisher Scientific Inc. is seeking an individual who demonstrates strong work behaviors to join our team as a Process Automation PCS/MES Engineer. This is a unique opportunity to work with a world-class organization that is dedicated to delivering exceptional products and services to our...
-
Scientist in Analytics, Process Development
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is a global leader in serving science with annual sales of more than $40 billion. Our mission is to help our customers make the world healthier, cleaner and safer. We support our customers advance life science research, solve complex analytical challenges, increase efficiency in their laboratories, improve patient health through...
-
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit: Management and staffing of the technical team: Process Automation Engineers (PCS/CUA/FMS) and MES Engineers internals and contingent workers Collaborate with diverse teams to design, develop, and implement process automation solutions using PCS/MES systems. Lead the operations of the team to ensure flawless delivery of automation solutions. Collaborate...
-
Head of Manufacturing Science and Technology
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Biologics Lengnau VollzeitA day in the Life: Leads the Manufacturing Science and Technology department and is responsible for processrelated activities enabling Drug Substance manufacturing of Biologics. Is responsible for facility fit assessment, tech transfer activities, coordination of process startup activities including Engineering Runs, GMP/clinical, PPQ and routine commercial...
-
Lengnau BE, Bern, Schweiz ThermoFisher Scientific VollzeitWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAre you ready to take your engineering career to the next level? Thermo Fisher Scientific Inc. is seeking an individual who demonstrates strong work behaviors to join our team as a Process Automation PCS/MES Engineer. This is a unique opportunity to work with a world-class organization that is...
-
Lengnau BE, Bern, Schweiz ThermoFisher Scientific VollzeitWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionAre you ready to take your engineering career to the next level? Thermo Fisher Scientific Inc. is seeking an individual who demonstrates strong work behaviors to join our team as a Process Automation PCS/MES Engineer. This is a unique opportunity to work with a world-class organization that is...
-
Head of Manufacturing Science and Technology
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...
-
Manufacturing Support Technician
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Biologics Lengnau VollzeitA day in the Life of a Manufacturing Support TechnicianProject duties: During design and start up of new production line: support operational readiness in area of expertise such as material management, cleanroom room readiness, training, compliance Participates in Technology Transfer of new productsSupports CVQ, PQ, Process Validation execution Is...
-
Manager Manufacturing Operation
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific Vollzeit: Responsible for the daily operations of Upstream processes in manufacturing suites, including schedule, shift rotations Lead and develop Manufacturing Team in order to run areas robustly and efficiently, ensuring appropriate succession planning Participates in defining robust process parameters during routine manufacturing campaigns Build...
-
Team Leader Manufacturing
vor 1 Woche
Lengnau BE, Bern, Schweiz Thermo Fisher Scientific VollzeitThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, growing efficiency in their laboratories,...
-
Manufacturing Professional
vor 1 Woche
Lengnau BE, Bern, Schweiz FLEXSIS VollzeitEINFÜHRUNG: Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.With 25 years of experience and expertise, we offer companies unique and individual solutions in personnel...
-
Manufacturing Professional
vor 1 Woche
Lengnau BE, Bern, Schweiz FLEXSIS VollzeitINTRODUCTION :Flexsis is part of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customized solutions in personnel consulting.With 25 years of experience and expertise, we offer companies unique and individual solutions in personnel...
