Why SimoTech
What is it like to
work at SimoTech? With a strong collaborative teamwork culture
based on respect, trust, and excellence, we play a critical
partnering role in our clients’ life-changing supply of products
to patients. In return, there is an excellent salary, benefits,
career progression, educational support and much more.
Automation CSV Engineer
We are actively
expanding our US projects team to support a growing portfolio of pharmaceutical
and biotechnology projects across the United States. SimoTech is seeking an
Automation CSV Engineer to join our team. The successful
candidate will support the validation of computerised systems within the
process automation framework, ensuring their compliance with pharmaceutical
industry standards and regulations. The ideal candidate will have extensive
experience as a CSV Engineer in a pharmaceutical environment.
- Develop
and execute validation strategies for new and existing process automation and
computerised systems.
- Support
the implementation and validation of DeltaV, Siemens PLC, PI and other
automation platforms.
- Prepare
and review validation documents including URS, FRS, IQ, OQ, PQ, Validation
Plans, Summary Reports and Automation Change Pack (ACP’s).
- Develop
and execute PV and PQ protocols to support readiness for commercial
manufacturing.
- Perform
risk assessments, impact assessments, and manage change controls for validated
systems.
- Create
and maintain traceability matrices ensuring full alignment between
requirements, design, and testing.
- Identify,
troubleshoot, and resolve validation deviations and test failures in a timely
manner.
- Execute
commissioning and qualification test cases to verify system functionality and
data integrity.
- Support
internal audits, inspection readiness, and preparation activities for
regulatory licensure (HPRA, EMA, FDA).
- Ensure
all validation work complies with 21 CFR Part 11, GAMP 5, EU Annex 11, and site
quality standards.
- Collaborate
with IT QA to ensure compliance and drive continuous improvement in validation
processes.
- Provide
validation and regulatory training to team members to support the transition
from project phase to operations.
Requirements
Key Requirements
- Bachelor’s
Degree in Engineering, Information Systems, Computer Science or Life Sciences.
- Minimum
of 5 years’ experience as a CSV Engineer in a pharmaceutical environment.
- Experience
supporting process automation systems and manufacturing technologies from a CSV
perspective.
- Good knowledge of 21 CFR Part
11, EU Annex 11, GAMP5 and data integrity guidelines.
- Hands
on experience validating DeltaV and Siemens PLC automated systems.
- Excellent
Communication and stakeholder management skills
- Ability to
work independently while contributing effectively within a team environment
- Eligibility
to work in the United States.
Benefits
What
SimoTech Can Offer
- Opportunity
to work with large corporate clients on exciting capital projects.
- Role provides a high degree of autonomy to allow the successful
candidate to reach their full potential.
- Develop
new skills and enhance technical ability by working with innovative
technologies in
- We offer
a hybrid working model for this role, balancing flexibility with business
needs.
Additional
Information
SimoTech is proud to
be an EEO Employer and does not discriminate on the basis of age, race, colour,
religion, gender identity, sex, gender expression, sexual orientation, genetic
information, ancestry, national origin, protected veteran status, disability,
or any other legally protected status