QCS Staffing
CSV Engineer
QCS Staffing - Seattle, Washington, us, 98127
Work at QCS Staffing
Overview
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Overview
CSV Engineer - USA, Seattle - 18 Month Contract
Our client, a global biotechnology organisation, is recruiting for a CSV Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV Engineer to help expand our client's biotech operations throughout Europe. As the CSV Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2. CSV Engineer - USA, Seattle - 18 Month Contract
Our client, a global biotechnology organisation, is recruiting for a CSV Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV Engineer to help expand our client's biotech operations throughout Europe. As the CSV Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.
Responsibilities
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies. Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities. Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports. Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures. Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed. Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations. Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices. Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems. Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation. Qualification of laboratory analytical instruments (e.g Cell Viability Analysers, Liquid Handlers etc.) Qualification of manufacturing automation systems (e.g DeltaV, MES etc.)
Requirements:
Bachelor's degree in Computer Science, Engineering, or a related field. Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology. Familiarity with validation methodologies, including risk-based validation approaches. Proficiency in creating and executing validation protocols and documenting validation activities. Excellent analytical and problem-solving skills, with attention to detail. Strong communication and interpersonal skills to collaborate effectively with cross-functional teams. Ability to work independently and manage multiple projects simultaneously. Knowledge of software development life cycle (SDLC) and change control processes. Understanding of data integrity principles and practices.
If this role is of interest, apply now!
Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
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Our client, a global biotechnology organisation, is recruiting for a CSV Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV Engineer to help expand our client's biotech operations throughout Europe. As the CSV Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2. CSV Engineer - USA, Seattle - 18 Month Contract
Our client, a global biotechnology organisation, is recruiting for a CSV Engineer to join their capital project in Seattle. This new build facility will house a therapeutic protein production plant, and we are looking for a CSV Engineer to help expand our client's biotech operations throughout Europe. As the CSV Engineer you will be responsible for implementing all safety requirements for a new build facility, estimated at approximately 14,900m2.
Responsibilities
Develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for computer systems and software applications. Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure compliance with regulatory guidelines and internal policies. Perform risk assessments and impact analyses to identify critical system functionalities and potential vulnerabilities. Create and maintain validation documentation, such as validation plans, test scripts, traceability matrices, and validation summary reports. Conduct periodic reviews to ensure ongoing compliance with regulatory requirements and internal procedures. Participate in change control processes, assessing the impact of system changes and ensuring appropriate validation activities are performed. Provide guidance and support to project teams regarding CSV principles, best practices, and regulatory expectations. Stay updated with industry trends, regulatory changes, and advancements in computer system validation practices. Collaborate with vendors and suppliers to ensure compliance with validation requirements for third-party systems. Support regulatory inspections and audits by providing documentation and participating in direct audit discussions related to computer system validation. Qualification of laboratory analytical instruments (e.g Cell Viability Analysers, Liquid Handlers etc.) Qualification of manufacturing automation systems (e.g DeltaV, MES etc.)
Requirements:
Bachelor's degree in Computer Science, Engineering, or a related field. Strong knowledge of regulatory guidelines, such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. Experience in computer system validation within a regulated industry, preferably pharmaceuticals or biotechnology. Familiarity with validation methodologies, including risk-based validation approaches. Proficiency in creating and executing validation protocols and documenting validation activities. Excellent analytical and problem-solving skills, with attention to detail. Strong communication and interpersonal skills to collaborate effectively with cross-functional teams. Ability to work independently and manage multiple projects simultaneously. Knowledge of software development life cycle (SDLC) and change control processes. Understanding of data integrity principles and practices.
If this role is of interest, apply now!
Seniority level
Seniority level Entry level Employment type
Employment type Contract Job function
Job function Engineering and Information Technology Industries Staffing and Recruiting Referrals increase your chances of interviewing at QCS Staffing by 2x Get notified about new Engineer jobs in
Seattle, WA . Seattle, WA $99,500.00-$200,000.00 6 days ago Seattle, WA $99,500.00-$200,000.00 6 days ago Seattle, WA $150,500.00-$269,200.00 6 days ago Seattle, WA $117,760.00-$147,200.00 2 weeks ago Seattle, WA $120,300.00-$168,700.00 3 days ago Seattle, WA $140,000.00-$180,000.00 2 months ago California, United States $100,000.00-$720,000.00 1 week ago Seattle, WA $140,000.00-$180,000.00 2 months ago Seattle, WA $110,400.00-$138,000.00 1 week ago Bellevue, WA $157,000.00-$230,000.00 2 weeks ago Seattle, WA $99,500.00-$200,000.00 2 weeks ago Software Development Engineer - 2025 (US)
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#J-18808-Ljbffr