RIT Solutions, Inc.
Job Title: PCS 7 Validation Engineer
Location:
Woodinville, WA (Hybrid - 3 days onsite in Redmond, WA)
Job Title: PCS 7 Validation Engineer
Overview: We are seeking a highly skilled and detail-oriented
PCS 7 Validation Engineer
to join our Automation/Validation team. This role will focus on developing and maintaining validation documentation for
Siemens PCS 7 control systems
within a regulated GxP environment. Your expertise will ensure compliance with FDA, EU, and GAMP 5 standards while supporting system readiness for production. Although primarily a documentation-focused position, you may also provide on-site execution support.
Key Responsibilities
Develop, write, and maintain standardized CSV templates and test protocols for Siemens PCS 7 systems.
Collaborate with cross-functional teams (Automation, Manufacturing, Quality, Engineering) to define system functionality and testing requirements.
Ensure validation documentation aligns with
GAMP 5, FDA 21 CFR Part 11, EU Annex 11 , and internal SOPs.
Support execution of validation protocols (equipment setup, test witnessing, documentation, troubleshooting).
Document and assist in investigating deviations/non-conformances.
Generate summary reports on validation activities.
Required Qualifications
3+ years of experience in validation within a
GxP regulated industry
(Pharma, Bio-Pharma, Medical Device, etc.).
Hands-on experience with
Siemens PCS 7 architecture
and components (OS, BATCH, Historian, etc.).
Strong background in drafting/authoring validation documents (IQ/OQ/PQ) for process control systems.
Solid knowledge of
FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 .
Excellent technical writing and communication skills with attention to detail.
Ability to work independently in a fast-paced project environment.
Woodinville, WA (Hybrid - 3 days onsite in Redmond, WA)
Job Title: PCS 7 Validation Engineer
Overview: We are seeking a highly skilled and detail-oriented
PCS 7 Validation Engineer
to join our Automation/Validation team. This role will focus on developing and maintaining validation documentation for
Siemens PCS 7 control systems
within a regulated GxP environment. Your expertise will ensure compliance with FDA, EU, and GAMP 5 standards while supporting system readiness for production. Although primarily a documentation-focused position, you may also provide on-site execution support.
Key Responsibilities
Develop, write, and maintain standardized CSV templates and test protocols for Siemens PCS 7 systems.
Collaborate with cross-functional teams (Automation, Manufacturing, Quality, Engineering) to define system functionality and testing requirements.
Ensure validation documentation aligns with
GAMP 5, FDA 21 CFR Part 11, EU Annex 11 , and internal SOPs.
Support execution of validation protocols (equipment setup, test witnessing, documentation, troubleshooting).
Document and assist in investigating deviations/non-conformances.
Generate summary reports on validation activities.
Required Qualifications
3+ years of experience in validation within a
GxP regulated industry
(Pharma, Bio-Pharma, Medical Device, etc.).
Hands-on experience with
Siemens PCS 7 architecture
and components (OS, BATCH, Historian, etc.).
Strong background in drafting/authoring validation documents (IQ/OQ/PQ) for process control systems.
Solid knowledge of
FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 .
Excellent technical writing and communication skills with attention to detail.
Ability to work independently in a fast-paced project environment.