CSV Consultant - West Coast ProPharma Group -
West, TX
ProPharma Group is an industry leader providing validation, compliance and technical services to the pharmaceutical, biotechnology, medical device and related industries. We offer the excitement of a consistently evolving career. Our team is continually learning and working on new and exciting projects in a variety of regions. We look for people who excel in their technical area of expertise, believe in our values of Experience, Integrity and Commitment and thrive in the collaborative, rigorous and entrepreneurial spirit of the company culture.
o Competitive Rates o New Experiences o Evolving Career
ProPharma Group develops long-term relationships with clients across the country to which we provide a wide array of value-added services that complement and support their core business needs.
Responsibilities:
A Computer Validation Engineer at ProPharma Group will work with our Clients and be responsible for the CSV processes of the company. Maintain expertise in current and emerging cGMP equirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11). Considered a Subject Matter Expert (SME) in terms of qualification for at least one type of system. Individual will work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule. Able to lead a system qualification effort and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply. Demonstrate expertise in at least one aspect of system qualification and regulatory compliance (e.g., EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
Qualifications:
Qualified candidates will possess a Bachelor’s degree in scientific or engineering discipline along with 5 plus years of experience in the field of computer validation.
Candidates must have excellent verbal communication and technical writing skills.
Proficient in Microsoft Word, Excel, Power Point and Project.
Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
Experience in development of Validation Master Plans for simple systems or facilities.
Experience in Project execution within at least one area of systems validation – e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems.
Ability to take and perform complex validation assignments, quality assurance assignments (where applicable) and other related job assignments as may be necessary for execution of the specific job activities.
Understanding of computer networking essentials and troubleshooting skills including but not limited to Windows OS, Server OS, SQL Server, Ethernet, TCP/IP, ODBC, SMTP, DHCP, routing, and switching.
Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
Carry out duties and responsibilities with limited supervision.
Flexibility to work occasional weekends and evenings.
Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
Ability to plan and manage own work
Must be willing to travel regionally and/or nationally throughout the US.
We are an equal opportunity employer. M/F/D/V
ProPharma Group - 9 months ago
- save job
-
block
