CSV Engineer

About PSC Biotech

Who we are

PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.

Take your Career to a new Level

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.

Requirements

Essential Duties and Responsibilities:

Recognise exemplify and adhere to companys values which centres around our commitment to People Clients and Performance.

As a member of staff the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

Must be able to plan and lead validation and qualification activities for multiple complex projects of any size which may be regional or global in scope and are occurring at the same time ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by and the FDA. Candidates must hold a strong emphasis on Agile and Automated Testing using tools like Jira Jenkins Confluence etc.

Must be able to coordinate multiple validation and qualification activities with project teams various departments and external vendors. These activities include Installation Qualification (IQ); System Testing which covers Operational Qualification (OQ) Performance Qualification (PQ) Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.

Must be able to conduct meetings for a Risk Impact Assessment (RIA) Validation Risk Assessment and 21 CFR Part 11 Assessment.

Must be able to create a User Requirements Specification and assist in the creation of a Functional Requirements Specification and the Technical Design Specification.

Must be able to create all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer III or below.

Must be able to review all System Delivery Life Cycle (SDLC) deliverables provide constructive feedback and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).

Must be completely proficient in all Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving all System Delivery Life Cycle (SDLC) deliverables that are delineated for a Validation Engineer III or below.

Must be able to create review and update SOPs and WPs associate with SDLC.

Must be able to conduct and approve a Periodic Review of computer system validation documentation including change control documentation to ensure that the validated state of a system has been maintained over time.

Must be able to create update and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations such as 21 CFR Part 11 to personnel.

Must be capable of representing Validation Services during sponsor audits and conducting external vendor audits.

Focus on meeting project schedules; conducting SDLC Validation or Installation Qualification training; and collects metrics.

Keep supervisor and project managers informed of any validation or qualification issues.

Additional duties as deemed appropriate by the department head/designee.

Requirements

Job Requirements:

Bachelor s degree or local equivalent in computer science mathematics information systems information technology or a related field.

EU/APAC: In depth proven experience in computer system validation preferably in clinical systems.

US/LATAM/CAN: A minimum of 5 7 years experience in computer system validation preferably in clinical systems.

Strong CSV experience with Agile SDLC

Testing Experience

Must have a solid background in hardware and software required to produce a network topology diagram and to ensure that all installation steps are present in an IQ Protocol.

Considerable knowledge of software development life cycles.

Must be experienced in serving as technical liaison between end users and testers.

Proficient with 21 CFR Part 11 ICH guidelines and FDA regulations on computer system validation.

Excellent interpersonal written and verbal communication skills; flexible; works well on a team; strong problemsolving ability; good project management skills and excellent collaborative skills.

Ability to work independently on all assignments meets deadlines and provides guidance to lowerlevel validation personnel.

Essential Duties and Responsibilities: Recognise, exemplify, and adhere to company's values which centres around our commitment to People, Clients, and Performance. As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Must be able to plan and lead validation and qualification activities for multiple complex projects of any size, which may be regional or global in scope and are occurring at the same time, ensuring that the activities conducted are fully compliant with industry regulations and guidelines as required by and the FDA. Candidates must hold a strong emphasis on Agile and Automated Testing, using tools like Jira, Jenkins, Confluence etc. Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control. Must be able to conduct meetings for a Risk Impact Assessment (RIA), Validation Risk Assessment and 21 CFR Part 11 Assessment. Must be able to create a User Requirements Specification and assist in the creation of a Functional Requirements Specification and the Technical Design Specification. Must be able to create all System Delivery Life Cycle (SDLC) deliverables that are authored by Validation Engineer III or below. Must be able to review all System Delivery Life Cycle (SDLC) deliverables, provide constructive feedback, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs). Must be completely proficient in all Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving all System Delivery Life Cycle (SDLC) deliverables that are delineated for a Validation Engineer III or below. Must be able to create, review, and update SOPs and WPs associate with SDLC. Must be able to conduct and approve a Periodic Review of computer system validation documentation, including change control documentation, to ensure that the validated state of a system has been maintained over time. Must be able to create, update, and present training material associated with all aspects of the System Delivery Life Cycle (SDLC) and FDA regulations, such as 21 CFR Part 11, to personnel. Must be capable of representing Validation Services during sponsor audits and conducting external vendor audits. Focus on meeting project schedules; conducting SDLC, Validation, or Installation Qualification training; and collects metrics. Keep supervisor and project managers informed of any validation or qualification issues. Additional duties as deemed appropriate by the department head/designee. Requirements Job Requirements: Bachelor s degree, or local equivalent, in computer science, mathematics, information systems, information technology or a related field. EU/APAC: In depth proven experience in computer system validation, preferably in clinical systems. US/LATAM/CAN: A minimum of 5- 7 years experience in computer system validation, preferably in clinical systems. Strong CSV experience with Agile SDLC Testing Experience Must have a solid background in hardware and software required to produce a network topology diagram and to ensure that all installation steps are present in an IQ Protocol. Considerable knowledge of software development life cycles. Must be experienced in serving as technical liaison between end users and testers. Proficient with 21 CFR Part 11, ICH guidelines, and FDA regulations on computer system validation. Excellent interpersonal, written, and verbal communication skills; flexible; works well on a team; strong problem-solving ability; good project management skills and excellent collaborative skills. Ability to work independently on all assignments, meets deadlines, and provides guidance to lower-level validation personnel.