BEPC Incorporated
Overview
BEPC is actively looking for a Validation Engineer II
to join the Hillsboro, OR site. This is a W2 contract role for 1 year with possible extensions, onsite. Benefits include medical, dental, vision, and life insurance. Pay rate:
$77.00 - $84.00/hour , determined based on experience. Note: This is a W2-only role C2C, C2H will not be considered. Responsibilities Be responsible for the review of system documentation according to the CSV SOPs and regulatory guidance. Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners. Apply ALCOA+ principles to validation deliverables and quality management system records. Support deviation investigations to identify root causes and define corrective and/or preventative actions. Support system audit/inspection preparation and execution as CSV subject matter expert. Complete or orchestrate timely completion of post-audit action items. Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready. Support system periodic reviews according to company procedures. Collaborate with local and global stakeholders in defining and completing validation and compliance activities. Perform other duties as assigned.
Qualifications
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field. Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry. Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus. Good knowledge of FDA regulations/guidance (e.g. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles. Good understanding of system and data risk assessment concepts. Take responsibility, drive results, and achieve expected outcomes. Effective communicator with excellent verbal and written communication skills. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals. Builds trustful and effective relationships. Able to think innovatively and translate ideas into actionable plans. Ability to work productively with stakeholders from different technical domains and cultures.
Preferred Qualifications
Knowledge of or experience with the following technical areas is a plus: System administration, software development, networking, server administration, MES Systems administration and recipe authoring, Industrial Data and manufacturing controls systems. Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow, is a plus. Keep abreast of key Manufacturing IT trends and be curious Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
About BEPC
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. Apply Now
Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you! #J-18808-Ljbffr
BEPC is actively looking for a Validation Engineer II
to join the Hillsboro, OR site. This is a W2 contract role for 1 year with possible extensions, onsite. Benefits include medical, dental, vision, and life insurance. Pay rate:
$77.00 - $84.00/hour , determined based on experience. Note: This is a W2-only role C2C, C2H will not be considered. Responsibilities Be responsible for the review of system documentation according to the CSV SOPs and regulatory guidance. Develop plans and reports such as validation plans/reports, test plans/reports (and other deliverables). Update existing validation deliverables and procedures in collaboration with the system owners. Apply ALCOA+ principles to validation deliverables and quality management system records. Support deviation investigations to identify root causes and define corrective and/or preventative actions. Support system audit/inspection preparation and execution as CSV subject matter expert. Complete or orchestrate timely completion of post-audit action items. Support system maintenance and enhancement activities, ensuring the validated state is kept, and it is audit and inspection ready. Support system periodic reviews according to company procedures. Collaborate with local and global stakeholders in defining and completing validation and compliance activities. Perform other duties as assigned.
Qualifications
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field. Minimum 6+ years experience in IT, OT or Software Technical Writing, Quality Systems, and Validation (CSV/CSA, GAMP), preferably in a regulated industry. Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus. Good knowledge of FDA regulations/guidance (e.g. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles. Good understanding of system and data risk assessment concepts. Take responsibility, drive results, and achieve expected outcomes. Effective communicator with excellent verbal and written communication skills. Ability to work collaboratively in cross-functional and agile teams to achieve milestones and goals. Builds trustful and effective relationships. Able to think innovatively and translate ideas into actionable plans. Ability to work productively with stakeholders from different technical domains and cultures.
Preferred Qualifications
Knowledge of or experience with the following technical areas is a plus: System administration, software development, networking, server administration, MES Systems administration and recipe authoring, Industrial Data and manufacturing controls systems. Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow, is a plus. Keep abreast of key Manufacturing IT trends and be curious Smart Buildings, Smart Manufacturing, Industrial IoT, Manufacturing Digital Plant Maturity, Cybersecurity, Pharma 4.0, Data Integrity principles, technology, and data standardization, etc.
About BEPC
BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. Apply Now
Qualified candidates are encouraged to apply by submitting an up-to-date resume that highlights how your experience aligns with the role. Please include specific examples that demonstrate your qualifications. We look forward to connecting with you! #J-18808-Ljbffr