CSV (WFI) Engineer
Company: PQE Group
Location: Rocky Mount
Posted on: August 3, 2022
PQE is a service provider company, leader in the Pharmaceutical
and Medical Device sectors since 1998. With a network of more than
900 consultants, PQE delivers the highest level of expertise to
Life Science customers worldwide and has successfully completed
12,000+ projects for 1,400+ clients. An international group, PQE
operates in over forty countries throughout Europe, Asia, and the
Americas. PQE offers worldwide coverage with offices and
representatives across Europe, North America, Asia, the Middle
East, and Latin America, in order to better serve these specific
local markets. Further information can be found at
www.pqegroup.com.Due to constant growth, PQE is looking for a new
Computer System Validation Lead. This will initially be a 6 month
contract assignment that will be worked on site in Rocky Mount, NC
with a possibility of extension.Responsibilities
- Support project activities within a cross functional project
- Perform verification activities to support process control
system start-up and verification. This includes documentation
development and approval.
- Communicate progress and issues to management.
- Follow standard operating procedures and standards in a highly
- GMP verification protocol generation and execution.
- Develop new standard operating procedures.
- Perform all tasks in strict compliance with best practices and
- Provide feedback to leadership regarding potential issues and
concerns with documentation.
- Adhere to safe work practices.Requirements
- Bachelor's degree in science, engineering or related
- At least 5 years of experience in validation of computerized
systems related to clean utilities (such as water for injection
systems, HVAC systems), process control system, SCADA systems and
process equipment's and qualification of IT infrastructure.
- Hands on experience in the development and/or execution of Risk
Assessments, Analysis of 21 CFR Part 11 Applicability/Requirements,
Traceability Matrix, Installation Qualification Protocol,
Operational Qualification Protocol, Qualification Reports and
Standard Operating Procedures.
- Experienced in Rockwell Factory Talk, Microsoft SQL Server,
Microsoft NET Framework and Allen Bradley PLC systems preferably
related to verification of process control systems.
- Previous work experience in verification of PLC, HMI, SCADA,
batch, and historian is required.
- Strong understanding of FDA regulations for commissioning,
validation, and lifecycle management of GMP equipment and
- Ability to manage priorities, deliverables, and schedule
- Requires strong interpersonal, verbal communication, and
technical writing skills.
Keywords: PQE Group, Rocky Mount , CSV (WFI) Engineer, Engineering , Rocky Mount, North Carolina
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