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Net2Source (N2S) • Portsmouth, New Hampshire, United States
Salary: 21CFR pa
Role & seniority: Senior CSV Engineer
Stack/tools: DeltaV (process control), Rockwell/Client, MES (Syncade), Pi Historian, SCADA, PLC; SDLC; 21 CFR Part 11/Annex 11; GAMP 5; Lonza change control; S88 (pref.), DeltaV recipe management (pref.), MES recipe authoring (pref.), QC system validation (pref.), Kneat (pref.)
Author, review, approve, and execute CSV lifecycle documentation; ensure data integrity and regulatory compliance
Implement and validate computerized systems (PCS DeltaV, Rockwell, MES Syncade, Pi Historian, SCADA, PLC); manage changes throughout SDLC per Lonza procedures
Independently and collaboratively contribute to validation efforts; support recipe management and validation activities where applicable
5+ years CSV/automation experience; strong SDLC knowledge; deep understanding of 21 CFR Part 11/Annex 11 and regulatory guidance (GAMP 5)
Experience implementing/validating DeltaV, PLC/SCADA, MES environments; strong verbal/written communication
S88 Batch Standard knowledge; Kneat experience; DeltaV recipe development/testing; MES recipe authoring; QC system validation
Location & work type: 100% onsite; location not specified; full-time/onsite engagement
Notes: Net2Source is a global staffing firm; role targets a senior CSV engineer with pharmaceutical/regulated industry focus.
Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring "Job Title" for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering.
This role is a senior CSV engineer requirement.
CSV /Automation experience of 5+ years
Hands on experience in Implementation & Validation of various computerized systems like PCS (DeltaV) / Client (Rockwell) / MES (Syncade) and Pi Historian / SCADA / PLC
Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.
Experienced at working independently as well as in a team-oriented, collaborative environment is essential
Author, Review, Approve and Execute CSV life cycle documentation
Experience working with and programming/commissioning/validating Delta V software platforms
Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation based systems
Manage, document, and assess the software changes throughout the SDLC following Lonza procedures.
Knowledgeable of S88 Batch Standard is preferable
Recipe management DeltaV software development and testing is preferable
MES Recipe authoring and testing is preferable
Implementation and validation of QC system is preferable
Experience with Kneat is preferable
Strong verbal and written communication skills
This role is 100% onsite.
About Net2Source, Inc. Net2Source is a total talent management solutions company with its presence in 50+ countries. Our creative solution service offerings aim at becoming your one stop destination for hiring talent needs globally. Want to read more about Net2Source? Visit us at www.net2source.com
Equal Employment Opportunity Commission The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 4100+ employees globally and 30+ locations in US and operations in 50+ countries. With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs. We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services.
Founded in 2007
100% Minority Owned, Debt Free, Private
4100+ consultants globally
2550 consultants placed in the US
750+ team of in-house staffing team
30+ sales offices in the US, and 50+ Offices globally
Operations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)
2020 Fast 100 Asian American Businesses by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC 2019)
2019 & 2018 Ranked 21st Fastest Growing Staffing Company in USA by Staffing industry Analysts
2019 & 2018 Fastest 50 by NJ Biz (Ranked (9th and 27th ).
2019 Top 100 Fastest companies to grow in Dallas by Dallas Business Journal.
INC 5000 Fastest growing for 8 consecutive years in a row.
America's Most Honored Businesses (Top 10%)
2019 Dallas Top 100 by Dallas Business Journal
2019 Proven Supplier of the Year by Workforce Logiq
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards Recruiter name Designation