GxP Validation Manager

Zifo•Bloomington, IN

About The Position

Zifo is looking for a GxP Validation –Manager to join our team in Bloomington, Indiana. Responsible for leading the GxP Validation and Remediation efforts for computer systems and/or analytical instruments in accordance with applicable policies procedures and regulatory requirements. 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.

Requirements

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.

Responsibilities

Define validation Strategy for computerized systems and/or analytical instruments utilized in GxP Space
Participate in user review meetings, discussions with Quality Assurance and Compliance groups
Participate/conduct Risk Assessments
Develop and maintain policies and procedures
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.
Participate in internal initiatives around Computer Systems Validation
Responsible for Project Risk Management, escalation management, stakeholder communication, status reporting etc.