Instrument and Controls Validation Engineer

Need a resource to complete the initial validation of the generic programming for capture purification. Will supplement staff to validate first STAR implementation of generic programming on Z-3076. Short term need approximately 3 months.
Plan and perform commissioning and validation (IQ, OQ, PQ) for the process control systems (Distributed Control systems, Programmable Logic Controllers, and the Building Management Systems). Responsible for validation of a single pre programmed capture skid (Z-3076). Work to include writing change requests and test protocols, obtain approvals, perform or supervise the changes and tests, compile results, complete documentation and write final reports. Write operating procedures and specifications, audit logbook entries, and review validation documents from other controls engineers. Experience with computer, controls systems and knowledge of cGMP methodologies and FDA regulations is required. Experience with control configuration and process instrumentation is a plus.
Need a BS or MS in Technical or Science Background with 6 to 10 years experience in Process/Computer validation in a cGMP environment. Experience with controls and computer operations and/or configuration. Experience with other DCS's as well as data gathering system (such as PI) is a plus. An understanding of basic computer operations including operating systems and network operations. Working knowledge of process instrumentation and other controls (e.g. single loop and PLC fundamentals). Should have a working background at a Biotech/Pharmaceutical production facility. Strong communication and teamwork skills are a requirement. Project management, along with production personnel interaction and support experience in a GMP production environment is preferred.

Job Title: Instrument and Controls Validation Engineer
Primary Skills: OQ; PLC; PQ; STAR; Validation; Z-3076; IQ
Job Industry: Biotech/Pharmaceutical
Vacancies: 1
Job City: Worcester
Job Metro Area: Worcester
Job State: MA
Job Country: US
Salary: DOE
Hours per Week: 40
Start Date: 09/05/2006
Job Duration: 3 - 6 months
Detailed Job Duration: 3 Months
Degree Type: BS
Degree Area: Engineering
Experience Minimum: 6 Years
Certificates/Licenses:

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