Computer and Equipment Validation

Planet Pharma Group; Newark (CA); On-site; USD 96,000 - 112,000; Full time

Job summary

Planet Pharma is seeking a validation SME to support validation of computerized systems, equipment, and instruments (systems). The role includes change control, data integrity assessments, and periodic review to ensure compliance with regulatory expectations.

You will define validation requirements, coordinate risk assessments, and manage test protocols (OQ, UAT) while working independently in a dynamic environment. US work authorization is required.

Qualifications

• A minimum B.S. degree in a scientific discipline is required.
• Minimum 6-8 years’ experience in qualifications/validations in the pharmaceutical or related industry.
• Must have CSV and/or CSA experience.

Responsibilities

• Periodic Review: Coordinate and support routine periodic system reviews.
• Validation: Author or support development of system lifecycle documents (e.g. risk assessments, user requirement specifications, test protocols).
• Qualification / Testing: coordinate, manage and/or execute test protocols (e.g. OQ, UAT), address exceptions, and review completed test packages.
• SDLC Support: support business owners, system owners, and other stakeholders through required system lifecycle activities.
• Data Integrity: Coordinate and support data integrity assessments.
• Compliance: ensure relevant electronic record, data integrity and other compliance requirements are defined for new systems per internal procedures and regulatory expectations.
• Change Control: Lead or support the system change control process as required.
• Supports and troubleshoots complex system issues

Skills

CSV/CSA experience

Regulatory awareness

Technical writing

Independent work

Education

B.S. in a scientific discipline

Tools

ERP validation

LIMS validation

MES validation

DMS validation

SAP change management

Job description

Duties:

We are seeking a validation SME to support validation of computerized systems, equipment, and instruments (systems). Primary responsibilities include supporting operational activities for existing systems such as change control, data integrity assessments, and periodic review. The role shall support the validation director to define validation / qualification requirements for new and existing systems, including issue tracking and resolution. The role requires flexibility and independent work in a dynamic environment.

Duties and Responsibilities:

• Periodic Review: Coordinate and support routine periodic system reviews
• Validation: Author or support development of system lifecycle documents (e.g. risk assessments, user requirement specifications, test protocols)
• Qualification / Testing: coordinate, manage and/or execute test protocols (e.g. OQ, UAT), address exceptions, and review completed test packages.
• SDLC Support: support business owners, system owners, and other stakeholders through required system lifecycle activities.
• Data Integrity: Coordinate and support data integrity assessments
• Compliance: ensure relevant electronic record, data integrity and other compliance requirements are defined for new systems per internal procedures and regulatory expectations.
• Change Control: Lead or support the system change control process as required
• Supports and troubleshoots complex system issues

Skills:

Position Requirements & Experience:

• A minimum B.S. degree in a scientific discipline is required
• Minimum 6-8 years’ experience in qualifications/validations in the pharmaceutical or related industry
• Must have CSV and/or CSA experience
• Previous experience in ERP, LIMS, MES and/or DMS system validation is required
• Technical writing
• Sound understanding of regulatory requirements and industry guidelines (21 CFR Part 11, GAMP 5, MHRA Data integrity guidelines, etc.)
• Experience with managing high-volume change control process, SAP change management a plus
• Experience of performing risk and change based impact assessments
• Experience with developing test strategies and designing right-sized test plans/protocols
• Must be able to independently organization, problem solve, multitask and prioritize work
• Work independently, elevate project issues and deliver results within established timelines

Candidates must be authorized to work in the U.S

Education:

• A minimum B.S. degree in a scientific discipline is required
• Minimum 6-8 years’ experience in qualifications/validations in the pharmaceutical or related industry

Pay Rate Range:

$70-81/hr depending on experience