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Executive Order 11246, Section 503 & VEVRAA EOE, including disability/vets
Documentation PLC Interpersonal And Communication Skills Written And Verbal Communi
 
Requirement id 108796
Job title Engineer
Job location in Providence, RI
Skills required Documentation, Bachelor Degree In Computer Science, MS Word, PLC Interpersonal And Communication Skil
Open Date 30-Jul-2020
Close Date
Job type Contract
Duration 7 Months
Compensation DOE
Status requirement ---
Job interview type ---
Apply
   Email Recruiter: coolsoft
Job Description Engineer: Documentation, Bachelor Degree In Computer Science, MS Word, PLC Interpersonal And Communication Skil

Note :6 month contract. role will be onsite 2-3 days per week must be local or able to relocate ASAP.

Candidate must be our W2 Employee.

Job Description :

Position: SR. CSV Engineer

Location: Providence, RI (must sit onsite 2-3 days per week)

Duration: 6 months

Position Description:

Our large pharmaceutical Client in Providence, RI is looking for Sr. CSV Engineer to join their team on a contract basis.

Responsibilities:

Draft and implement Quality System documentation designed to establish good validation practices within the Organization.

Work with system owners on Data Integrity and CSV assessment and provide guidance for CSV policies and procedures.

Design validation approaches, draft validation protocols, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.

Draft and execute IQ/OQ/PQ protocols for software, PLC hardware, and IT systems.

Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.

Assist in training and mentoring staff in the technical competencies of computer validation and in contributing to validation projects.

Execute assigned duties on time and within budget; pro-actively telegraph delays and other issues to relevant stakeholders.

Comply with all Regulatory, Corporate, and Quality System policies

Complete other projects and/or assignments as required.

Qualifications:

B.S. / M.S. in Computer Science or another relevant engineering discipline.

Minimum of 5+ years of experience working within regulated manufacturing. Direct experience with CSV of GxP systems is mandatory.

Demonstrated knowledge of cGMP manufacturing as well as regulatory regulations and requirements for medical devices, biotechnology, and pharmaceuticals with an emphasis on 21 CFR Part 11, including Annex 11, and Data Integrity.

Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc)

Familiarization with ISO 13485 and 21 CFR 820.

Proficient in Microsoft Word, Excel, PowerPoint.

Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.

Must demonstrate strong verbal, written, presentation, interpersonal and teamwork skills.

Additional Requirements:

Candidates may be subject to background check and drug test.
 
Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 108796 while calling.
 
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(Engineer: Documentation, Bachelor Degree In Computer Science, MS Word, PLC Interpersonal And Communication Skil in Providence, RI)
     
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