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

Manufacturing, Quality and Engineering to understand system

functionality and define testing requirements.

and regulatory requirements.

setting up test equipment, witnessing tests, documenting results, and

troubleshooting minor issues.

non-conformances encountered during testing.

activities.

Required Qualifications and Skills :

regulated industry (Pharma, Bio-Pharma, Medical Device, etc.).

components (OS, BATCH, Historian etc.).

IQ / OQ / PQ protocols) specifically for process control systems.

11, EU Annex 11, and GAMP 5 guidelines.

for detail and accuracy.

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.