AMARIS GROUP SA
MES Expert Pharmaceuticals [F/M/X]
AMARIS GROUP SA, Sauk Trail Beach, Wisconsin, United States
Limited reprogramming
(scope defined, focused on critical changes)
Full validation lifecycle .disconnect trending: (including test protocol development, execution, reporting, and post-upgrade monitoring)
No formal training provided
on the new version candidates must be self-sufficient and experienced.
Job Description
Limited reprogramming
(scope defined, focused on critical changes)
Full validation lifecycle
(including test protocol development, execution, reporting, and post-upgrade monitoring)
No formal training provided
on the new version candidates must be self-sufficient and experienced.
Key Responsibilities
Lead and execute the
end-to-end validation process
for the Siemens Opcenter upgrade:
Develop and finalize
test protocols
(using existing templates).
Perform
protocol reviews and approvalsAllow
with stakeholders.
Execute test cases and
track results
in real time.
Document and report findings, including
defects, deviations, and resolution status .
Prepare final
validation summary report
and support regulatory readiness.
Collaborate withTha
IT and automation teams
to ensure seamless integration and data integrity.
Conduct
post-upgrade monitoring
for
at least 2 months
to validate long‑term stability and performance.
Act обусловлен as a
subject matter expert (SME)
in MES validation and CSV (Computer System Validation) practices.
Ensure compliance with
GxP, ISO 13485, and EU Annex 11
standards where applicable.
Required Qualifications
Bachelor’s degree
in Engineering (Electrical, Industrial, Automation, or IT), Computer Science, or related field.
Minimum 5 years of experience
in
MES systems , preferably with Siemens Opcenter (formerly Tecnomatix, Teamcenter, or similar).
Mandatory FRENCH and ENGLISH fluent.
Proven experience in
CSV and validation lifecycle management
(IQ/OQ/PQ).
Strong understanding of
MES data flows, interfaces, and integration points .
Experience with
version upgrades
of enterprise manufacturing systems (especially in regulated environments).
Proficiency in
documentation, test case design, and defect tracking .
Ability to work
autonomously
with minimal supervision.
Excellent communication and stakeholder management skills.
Preferred Skills
Experience in
automated manufacturing environments
(pharma, medical devices, automotive, or high‑tech manufacturing).
Familiarity with
IT/automation project lifecycles
and cross‑functional collaboration.
Knowledge of
data integrity principles
and
audit readiness .
Experience with
Agile Willingness to work on‑site during critical upgrade windows (e.g., summer shutdowns).
Why joining us? Rapid growth:
Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects:
Candidatescepción with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment:
An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
Who are we? Amaris Consulting
is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:
Brief Call:
Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews
(the average touchscreen number of interviews is 3 – the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study:
Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem‑solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.
We look forward to meeting you!
#J-18808-Ljbffr
(scope defined, focused on critical changes)
Full validation lifecycle .disconnect trending: (including test protocol development, execution, reporting, and post-upgrade monitoring)
No formal training provided
on the new version candidates must be self-sufficient and experienced.
Job Description
Limited reprogramming
(scope defined, focused on critical changes)
Full validation lifecycle
(including test protocol development, execution, reporting, and post-upgrade monitoring)
No formal training provided
on the new version candidates must be self-sufficient and experienced.
Key Responsibilities
Lead and execute the
end-to-end validation process
for the Siemens Opcenter upgrade:
Develop and finalize
test protocols
(using existing templates).
Perform
protocol reviews and approvalsAllow
with stakeholders.
Execute test cases and
track results
in real time.
Document and report findings, including
defects, deviations, and resolution status .
Prepare final
validation summary report
and support regulatory readiness.
Collaborate withTha
IT and automation teams
to ensure seamless integration and data integrity.
Conduct
post-upgrade monitoring
for
at least 2 months
to validate long‑term stability and performance.
Act обусловлен as a
subject matter expert (SME)
in MES validation and CSV (Computer System Validation) practices.
Ensure compliance with
GxP, ISO 13485, and EU Annex 11
standards where applicable.
Required Qualifications
Bachelor’s degree
in Engineering (Electrical, Industrial, Automation, or IT), Computer Science, or related field.
Minimum 5 years of experience
in
MES systems , preferably with Siemens Opcenter (formerly Tecnomatix, Teamcenter, or similar).
Mandatory FRENCH and ENGLISH fluent.
Proven experience in
CSV and validation lifecycle management
(IQ/OQ/PQ).
Strong understanding of
MES data flows, interfaces, and integration points .
Experience with
version upgrades
of enterprise manufacturing systems (especially in regulated environments).
Proficiency in
documentation, test case design, and defect tracking .
Ability to work
autonomously
with minimal supervision.
Excellent communication and stakeholder management skills.
Preferred Skills
Experience in
automated manufacturing environments
(pharma, medical devices, automotive, or high‑tech manufacturing).
Familiarity with
IT/automation project lifecycles
and cross‑functional collaboration.
Knowledge of
data integrity principles
and
audit readiness .
Experience with
Agile Willingness to work on‑site during critical upgrade windows (e.g., summer shutdowns).
Why joining us? Rapid growth:
Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects:
Candidatescepción with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment:
An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.
Who are we? Amaris Consulting
is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:
Brief Call:
Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews
(the average touchscreen number of interviews is 3 – the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study:
Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem‑solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate’s shoes to ensure they have the best possible experience.
We look forward to meeting you!
#J-18808-Ljbffr