PCS 7 Validation Engineer

Job Title: PCS 7 Validation Engineer
Job Location: Redmond, WA Hybrid
Eligibility/Clearance: Must be authorized to work in the US

Job Description: We are looking for a highly skilled and detail-oriented
PCS 7 Validation Engineer to join our Automation/Validation team. In
this critical role, you will be responsible for developing, authoring,
and maintaining the foundational documentation required to validate
Siemens PCS 7 control systems in a regulated GxP environment. Your
expertise will be essential in ensuring our automated processes are
compliant with industry standards (e.g., FDA 21 CFR Part 11, EU Annex
11, GAMP 5) and are fit for their intended use. While the primary focus
is on document authoring, this role may also provide direct support for
the execution of validation activities on-site.

Key Responsibilities:

-Develop, write, and maintain standardized CSV templates and test
protocols for Siemens PCS 7 systems

-Collaborate with cross-functional stake holders across Automation,
Manufacturing, Quality and Engineering to understand system
functionality and define testing requirements.

-Ensure all validation documentation aligns with GAMP 5, internal SOPs,
and regulatory requirements.

-Support the execution of validation protocols, which may include
setting up test equipment, witnessing tests, documenting results, and
troubleshooting minor issues.

-Identify, document, and assist in the investigation of deviations and
non-conformances encountered during testing.

-Generate summary reports to formally document the outcome of validation
activities.

Required Qualifications and Skills:
-Proven experience (3+ years) in a validation role within a GxP
regulated industry (Pharma, Bio-Pharma, Medical Device, etc.).

-Must have hands-on experience with Siemens PCS 7 architecture and
components (OS, BATCH, Historian etc.).

-Demonstrable experience in drafting and authoring validation documents
(IQ/OQ/PQ protocols) specifically for process control systems.

-Strong understanding of relevant regulatory standards: FDA 21 CFR Part
11, EU Annex 11, and GAMP 5 guidelines.

-Excellent technical writing and communication skills, with a keen eye
for detail and accuracy.

-Ability to work independently and manage multiple priorities in a
fast-paced project environment.
Arena Technical Resources, LLC, (ATR) is an Equal Opportunity Employer
(EOE) who will provide equal employment opportunity to employees and
applicants for employment without regard to race, ethnicity, religion,
color, sex, pregnancy, national origin, age, veteran status, ancestry,
sexual orientation, gender identity or expression, marital status,
family structure, genetic information, or mental or physical disability.