IPS- Integrated Project Services is currenly looking for a Business Analyst/Computer System Validation Consultant in the Blue Bell, PA area.
Qualifications & Requirements
Gather information for creation of User requirement, Design Specs, Validation plan, Data integrity Plans etc
- Validation and Qualification on a large global GMP QC Laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
- Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
- Assist systems users with defining and documenting system use in user, admin, and maintenance SOPs
- Coordinate alignment of systems users from various company sites, including international sites, on validation and qualification documentation
- Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
- Provide tactical guidance and coaching in support of systems testing efforts
- take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
- 7+ years of BA and Lab Systems CSV experience is required; or 5+ years as user of Lab Systems with 7+ years of other CSV experience
- Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical GMP QC Lab Standalone COTS systems are required
- Strong Data Integrity concepts exp
- Experience working with systems users from different sites is required. Experience with international sites is highly desired.
- Excellent communication and written skills are required
IPS-Integrated Project Services is a global leader in developing innovative and cost effective solutions for the engineering, construction, commissioning and qualification of complex pharmaceutical and biotech research and manufacturing facilities. With technical expertise spanning R&D to pilot-scale to large-scale production, our team specializes in the technology, trends and regulatory environment to successfully deliver capital projects and improve operations. For over twenty years, we have applied unique LEAN methodologies throughout the project life cycle, continually finding ways to do things better and more efficiently, delivering higher quality and controlling costs. Headquartered in Blue Bell, PA, IPS is a multi-national company with over 1,000 professionals worldwide and offices in California, Indiana, Kansas, Massachusetts, New Jersey, North Carolina, Pennsylvania, Brazil, Canada, China, Singapore, Switzerland, UK and four locations in India. Visit our website at www.ipsdb.com.
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV and Staffing Services.
IPS is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V).
Attention Search Firms / Third Party Recruiters:
IPS is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with IPS. Regardless of past practice, all resumes submitted by search firms to any employee at IPS via-email, the Internet or directly to hiring managers at IPS in any form without a valid written search agreement in place for a specific position will be deemed the sole property of IPS, and no fee will be paid in the event a candidate is hired by IPS as a result of the referral or through other means.