Computer System Validation (CSV) Program Lead

Computer System Validation (CSV) Program LeadJob Number: 352755Category: -MFG & Supply Chain SBUDescription: Job Title: Hardware Program LeadLocation: Indianapolis, IN 46225, OnsitePay Rate: $50.00-60.00/hourEmployment Type: Full time, direct with a full benefits packageShift: 1st#CSVLeadership #PharmaValidation #ComplianceExcellenceOverview:We are seeking an experienced CSV (Computer System Validation) Program Lead to lead the validation deliverables for a large pharmaceutical automation program. This role involves working closely with subject matter experts, quality assurance teams, and management to ensure that all CSV processes comply with corporate quality standards and regulatory requirements.Key Responsibilities:

Lead the development and management of CSV deliverables for the automation solution.

Interface with Subject Matter Experts (SMEs), site management, and quality teams to gather key validation project information.

Draft key validation documents including Validation Plans, Security Plans, and Test Plans.

Support the generation of project CSV documents, such as the Project Validation Plan, Test Plan, and Electronic Testing Templates.

Ensure all CSV documentation complies with corporate quality standards and electronic document management system requirements.

Provide mentoring and guidance on CSV processes to cross-functional teams.

Support onboarding, training, and management of the CSV team and validation personnel.

Develop reports and track project progress using Change Management and Electronic Document Management systems.

Recommend improvements to enhance compliance and consistency in CSV deliverables.

Requirements:

Bachelor"s in Engineering or equivalent preferred.

10+ years of experience in CSV within the pharmaceutical industry.

Experience leading large pharmaceutical automation projects.

Strong knowledge of Electronic Document Management and Electronic Test Management systems.

Proficiency in managing multiple complex projects and strong attention to detail.

Excellent communication skills, with the ability to interact with both technical and non-technical stakeholders.

Apply Now:Join us as a CSV Program Lead and play a crucial role in ensuring the success of pharmaceutical automation projects. Drive innovation, compliance, and best practices in a leading pharmaceutical environment!Belcan (a Cognizant company) provides a competitive pay and benefits package. Benefits offered MAY include health, dental, vision, and life insurance; 401(k); education assistance; paid time off including PTO, holidays, and paid leave required by law. Salary guidelines for similar roles at Belcan are $50.00-60.00 per hour. Guidelines vary based on many factors including but not limited to education, qualifications, experience, discipline, geographic location, market, and business considerations.EOE/F/M/Disability/VeteransBuild a challenging and rewarding career with an industry leader!Location: Indianapolis , INMinimum Experience (yrs): 10+Required Education: Bachelor (BA, BS)Benefits: Return to search results Email this job to a friend (emailjobs.asp?jonum=352755) If you have previously registered with us, pleaseLog in (memberlogin.asp) to apply for this position.Logged in members may also add jobs to their job cart