We are seeking a highly skilled and motivated
MSAT Validation Expert
to join our client's team in the biopharmaceutical industry. In this role, you will play a critical part in ensuring compliance, quality, and operational excellence in
process and cleaning validation
within a large-scale manufacturing environment.
Key Responsibilities
Design, implement, and optimize validation strategies for
process and cleaning activities
in a cGMP-regulated biopharmaceutical manufacturing setting.
Draft, review, and finalize
validation protocols and reports
in compliance with global regulatory standards (e.g., FDA, Swissmedic, EMA).
Serve as a
technical authority
for non-conformity records, change requests, and validation assessments, ensuring robust decision-making and risk mitigation.
Lead and support
PQ studies , ensuring adherence to protocols and regulatory expectations.
Work closely with cross-functional teams, including
Quality Assurance, Manufacturing, and Regulatory Affairs , to align validation activities with business objectives and GMP standards.
Represent the organization in
customer-facing meetings and regulatory inspections , demonstrating compliance and operational excellence.
Identify opportunities for process optimization, leveraging data-driven insights and industry best practices.
Key Requirements
Master’s degree or PhD
in Biotechnology, Life Sciences, or a related field.
5+ years of experience
in
process validation , with a strong preference for expertise in
cleaning validation
within a
cGMP-regulated biopharmaceutical environment .
Proven track record in
MSAT (Manufacturing Science & Technology)
or
Quality roles , with experience in
upstream/downstream processes
(preferably in
mammalian cell culture ).
Experience in
process development, scale-up, or manufacturing
is highly desirable.
In-depth knowledge of
cGMP regulations
and
regulatory agency expectations
(e.g., FDA, Swissmedic, EMA).
Proficiency in
technical writing , including validation protocols, reports, and risk assessments.
Strong
project management
skills, with the ability to manage
complex, multi-stakeholder projects
and meet tight deadlines.
Familiarity with
statistical tools and data analysis
for validation studies.
Fluent in English
and
German
Exceptional
communication, stakeholder management , and
problem-solving
abilities.
#J-18808-Ljbffr
MSAT Validation Expert
to join our client's team in the biopharmaceutical industry. In this role, you will play a critical part in ensuring compliance, quality, and operational excellence in
process and cleaning validation
within a large-scale manufacturing environment.
Key Responsibilities
Design, implement, and optimize validation strategies for
process and cleaning activities
in a cGMP-regulated biopharmaceutical manufacturing setting.
Draft, review, and finalize
validation protocols and reports
in compliance with global regulatory standards (e.g., FDA, Swissmedic, EMA).
Serve as a
technical authority
for non-conformity records, change requests, and validation assessments, ensuring robust decision-making and risk mitigation.
Lead and support
PQ studies , ensuring adherence to protocols and regulatory expectations.
Work closely with cross-functional teams, including
Quality Assurance, Manufacturing, and Regulatory Affairs , to align validation activities with business objectives and GMP standards.
Represent the organization in
customer-facing meetings and regulatory inspections , demonstrating compliance and operational excellence.
Identify opportunities for process optimization, leveraging data-driven insights and industry best practices.
Key Requirements
Master’s degree or PhD
in Biotechnology, Life Sciences, or a related field.
5+ years of experience
in
process validation , with a strong preference for expertise in
cleaning validation
within a
cGMP-regulated biopharmaceutical environment .
Proven track record in
MSAT (Manufacturing Science & Technology)
or
Quality roles , with experience in
upstream/downstream processes
(preferably in
mammalian cell culture ).
Experience in
process development, scale-up, or manufacturing
is highly desirable.
In-depth knowledge of
cGMP regulations
and
regulatory agency expectations
(e.g., FDA, Swissmedic, EMA).
Proficiency in
technical writing , including validation protocols, reports, and risk assessments.
Strong
project management
skills, with the ability to manage
complex, multi-stakeholder projects
and meet tight deadlines.
Familiarity with
statistical tools and data analysis
for validation studies.
Fluent in English
and
German
Exceptional
communication, stakeholder management , and
problem-solving
abilities.
#J-18808-Ljbffr
MSAT Validation Expert (Process & Cleaning Validation) Arbeitgeber: ALTEN
ALTEN ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern nicht nur einen unbefristeten Arbeitsvertrag und flexible Arbeitszeiten bietet, sondern auch aktiv in die Entwicklung ihrer Karrieren investiert. Mit einem starken Fokus auf Vielfalt und Inklusion sowie einem unterstützenden Arbeitsumfeld fördert ALTEN eine positive Work-Life-Balance und bietet einzigartige Vorteile wie Dienstradleasing und Zugang zu Fitnessprogrammen. Hier hast du die Möglichkeit, an innovativen Projekten in der Luft- und Raumfahrt zu arbeiten und deine Fähigkeiten in einem dynamischen Team weiterzuentwickeln.
