Agile Programming Methodologies, Analysis Skills, Biomedical Engineering, Biotech and Pharmaceutical, Change Control, Change Management, Chromatographic Assay, Code of Federal Regulations, Communication Skills, Computer Science, Computer Skills, Computer Systems, Consulting, Customer/Client Research, Data Analysis, Data Quality, Diversity, Document Management, GLP (Good Laboratory Practices), GMP (Good Manufacturing Practices), GxP, Help Desk, Instrumentation, Laboratory, Laboratory Information Management System (LIMS), Manufacturing, Medical Equipment, Microbiology, Offshoring, Policy Development, Procedure Development, Project Control, Project Lifecycle, Quality Assurance, Quality Control, Regulatory Requirements, Requirements Management, Research & Development (R&D), Risk Analysis, Risk Management, Sequencers, Software Development Lifecycle (SDLC), Software Testing, Spectroscopy, System Validation, Systems Analysis, Team Player, Validation Documentation, Writing Skills
Location: Bloomington, IN
**This role will require full-time presence (5 days / week) at the client site in Bloomington, IN**
** This role is not eligible for relocation assistance**
Zifo is looking for a GxP Validation –Manager to join our team in Bloomington, Indiana.
Responsible for leading the GxP Validation, Data Integrity and Remediation efforts for Analytical Instruments and Computerized Systems in accordance with applicable policies procedures and regulatory requirements.
Job Responsibilities
- Define validation Strategy for computerized systems and analytical instruments utilized in GxP QC and Manufacturing labs
- Understand SDLC process and SDLC methodology such as agile etc.
- Create and support review of validation life cycle documents for Analytical Instrument Qualification and computerized systems
- Participate/conduct Risk Assessments
- Develop and maintain policies and procedures
- Experience in validation of analytical instrument systems (e.g. benchtop analytical systems - spectroscopy, chromatography, protein analyzers, next gen sequencers, PCRs etc.)
- Perform Data Integrity Assessments for analytical instruments and Computerized systems and conduct meetings with stakeholders to discuss on the remediations of observations from review. Consult clients on data integrity requirements in Analytical Instruments and perform verification of DI in the systems.
- Participate in user review meetings, discussions with Quality Assurance and Compliance groups
- Must have experience working with global team (offshore) in delivering validation project deliverables and collaborate with global team towards project success.
- Effectively communicate the validation activities and deliverables to the project team, customer stake holders and global team within Zifo
- Act as a liaison between Zifo remote teams and customers
- Responsible for Project Risk Management, escalation management, stakeholder communication, status reporting etc.
- Author/Review validation life cycle documents for client’s review and approval
- 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 for documents
- Execute approved qualification protocols in GxP facility along with SMEs. Must be aware of using electronic document management systems to create and execute qualification protocols
- Understand and manage change controls necessary for project life cycle through process compliance and interface with Quality Assurance change control area
- Participate in internal initiatives around Compliance and Validation
Requirements
Qualifications
- Bachelor or Master’s degree in Lifesciences or Computer Sciences
- 7+ years’ experience with Computer Systems Validation is required for this role
- Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11, 210, 211, EU Annex 11, 15 requirements
- Experience with laboratory or GxP systems validation like ELN, LIMS, QMS and Instrumentation Systems etc.
- Experience with working on long term multiple site engagements and remediation programs.
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.