Intellectt Inc
Validation Engineer (Automation)
Duration:
12+ Months - Onsite
Employment Type:
Contract (W2/1099 Only – No C2C)
Position Overview Our client is seeking a Validation Engineer (Automation) to support the Building A Suite AB Vax Project, focusing on autoclave qualification. The engineer will deliver automation and validation services across design, commissioning, qualification, and post-OQ support, ensuring PLC, SCADA/MCS systems, and GMP documentation meet regulatory standards.
Key Responsibilities
Review and approve software specifications and automation documentation.
Implement and test PLC modifications for autoclave systems (minimum of two).
Design and develop SCADA/MCS screens and reports per user and process requirements.
Perform SQL and OSI PI database updates for data collection, trending, and reporting.
Author and execute Functional Specifications (FS), Configuration Specifications (CS), SOPs, and Data Integrity (DI) Assessments.
Support FAT, SAT, and site installation to ensure compliance with URS and design intent.
Lead or support system commissioning, IQ, OQ, and PQ documentation and execution.
Maintain system drawings and configuration records as part of change control.
Provide post‑OQ hyper‑care support, troubleshooting, and corrective actions as needed.
Ensure compliance with GMP, GAMP 5, and data integrity principles.
Required Qualifications
Bachelor’s degree in Engineering (Electrical, Mechanical, Automation, or related field).
5+ years of experience in automation or validation engineering within pharmaceutical or biotech manufacturing.
Hands‑on experience with PLC (Allen‑Bradley, Siemens, etc.), SCADA/MCS, and OSI PI systems.
Strong understanding of GMP, 21 CFR Part 11, and GAMP 5 requirements.
Experience authoring and executing validation and qualification protocols (IQ/OQ/PQ).
Familiarity with autoclave or sterilization equipment validation preferred.
Excellent technical writing and communication skills.
Preferred Skills
Experience with Emerson DeltaV, Rockwell Automation, or Wonderware/AVEVA systems.
Knowledge of data integrity assessment and change control processes.
Experience in biologics or vaccine manufacturing projects.
Ability to work independently and cross‑functionally in a fast‑paced environment.
Location & Salary Boston, MA Salary: $50,000.00 – $80,000.00
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12+ Months - Onsite
Employment Type:
Contract (W2/1099 Only – No C2C)
Position Overview Our client is seeking a Validation Engineer (Automation) to support the Building A Suite AB Vax Project, focusing on autoclave qualification. The engineer will deliver automation and validation services across design, commissioning, qualification, and post-OQ support, ensuring PLC, SCADA/MCS systems, and GMP documentation meet regulatory standards.
Key Responsibilities
Review and approve software specifications and automation documentation.
Implement and test PLC modifications for autoclave systems (minimum of two).
Design and develop SCADA/MCS screens and reports per user and process requirements.
Perform SQL and OSI PI database updates for data collection, trending, and reporting.
Author and execute Functional Specifications (FS), Configuration Specifications (CS), SOPs, and Data Integrity (DI) Assessments.
Support FAT, SAT, and site installation to ensure compliance with URS and design intent.
Lead or support system commissioning, IQ, OQ, and PQ documentation and execution.
Maintain system drawings and configuration records as part of change control.
Provide post‑OQ hyper‑care support, troubleshooting, and corrective actions as needed.
Ensure compliance with GMP, GAMP 5, and data integrity principles.
Required Qualifications
Bachelor’s degree in Engineering (Electrical, Mechanical, Automation, or related field).
5+ years of experience in automation or validation engineering within pharmaceutical or biotech manufacturing.
Hands‑on experience with PLC (Allen‑Bradley, Siemens, etc.), SCADA/MCS, and OSI PI systems.
Strong understanding of GMP, 21 CFR Part 11, and GAMP 5 requirements.
Experience authoring and executing validation and qualification protocols (IQ/OQ/PQ).
Familiarity with autoclave or sterilization equipment validation preferred.
Excellent technical writing and communication skills.
Preferred Skills
Experience with Emerson DeltaV, Rockwell Automation, or Wonderware/AVEVA systems.
Knowledge of data integrity assessment and change control processes.
Experience in biologics or vaccine manufacturing projects.
Ability to work independently and cross‑functionally in a fast‑paced environment.
Location & Salary Boston, MA Salary: $50,000.00 – $80,000.00
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