Validation Analyst

Zifo; Norwood (MA); On-site; USD 110,000 - 160,000; Full time

Job summary

Zifo is seeking a highly motivated professional to lead validation strategy and planning, and to execute and qualify computer systems and analytical instruments in line with regulatory requirements. The role involves creating validation lifecycle documents, supporting DI/data integrity, and collaborating with global teams to deliver compliant validation project deliverables.

The ideal candidate will have 5+ years in Validation/QA in pharma/Life sciences, experience with benchtop instruments and

Qualifications

• Experience in validating analytical instrument systems and computerized systems.

Responsibilities

• Create and support validation life cycle documents for Analytical Instrument Qualification and computerized systems
• Experience in validation of analytical instrument systems (benchtop systems etc.)

Skills

Benchtop instruments validation

Robotic workstations validation

Validation lifecycle documents

Data integrity consulting

Quality Assurance change control

SDLC & Agile

Cross-functional collaboration

GxP compliance

Document routing & approvals

Education

Bachelor's or Master's degree in science/healthcare

Job description

Zifo is seeking a highly motivated and energetic professional to be responsible for validation strategy and planning, executing and qualification of computer systems and/or analytical instruments in accordance with applicable policies procedures and regulatory requirements.

Curious about this position?

Zifo is seeking a highly motivated and energetic professional to be responsible for validation strategy and planning, executing and qualification of computer systems and/or analytical instruments in accordance with applicable policies procedures and regulatory requirements.

Requirements

• Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
• Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)
• Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems
• Author validation life cycle documents for client's review and approval
• Perform Periodic review for the analytical instruments and conduct meetings with stakeholders to discuss on the remediations of observations from review
• IT audit trail review and conduct meetings with stakeholders to discuss on the remediations of observations from review
• Act as a business consultant to support end users of the system
• Route drafted documents for review
• Route reviewed documents for workflow approval
• Request approval workflows to Doc Control
• Execute approved protocols in GxP facility
• Understand SDLC process and SDLC methodology such as agile etc
• Work with global team in delivering validation project deliverables
• Manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
• Author change control documents for client review and approval

Qualifications{{:}}

• Prior experience with benchtop instrument experience is a must
• Prior experience with validating robotic workstations is a must
• Bachelor's/ Master's degree or equivalent in a scientific or health care field
• 5+ years' experience in a Validation/ Quality assurance / control role, preferably in the pharmaceutical /Life sciences industry preferred

Benefits

CURIOSITY DRIVEN, SCIENCE FOCUSED, EMPLOYEE BUILT. Our culture is unlike any other, one where we debate, challenge ourselves, and interact with all alike. We are a curious bunch, characterized by our passion to learn and spirit of teamwork. Zifo is a global R&D solutions provider focused on the industries of Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals and other research-based organizations. Our team's knowledge of science and expertise in technology help Zifo better serve our customers around the globe, including 18 of the Top 20 Biopharma companies.

We look for Science - Biotechnology, Pharmaceutical Technology, Biomedical Engineering, Microbiology etc. We possess scientific and technical knowledge and bear professional and personal goals. While we have a "no doors" policy to promote free access within, we do have a tough door to walk in.We search with a two-point agenda - technical competency and cultural adaptability.

We offer a competitive compensation package including accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.

If you share these sentiments and are prepared for the atypical, then Zifo is your calling!

Zifo is an equal opportunity employer, and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.