Product Validation Engineering Manager
Flock Safety$170,000 - $220,000/year
Full Time
Expert & Leadership (9+ years), Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharma, BiotechIndustries
Requirements
- Bachelor or Master’s degree in Lifesciences or Computer Sciences
- 5+ years’ experience with Computer Systems Validation
- Strong knowledge of GxP Requirements, GLP and GMP regulations, 21 CFR part 11 requirements
- Experience with laboratory or GxP systems validation like ELN, LIMS, QMS etc
- Independent, Self-Motivated & Results driven
- Willing & able to quickly acquire new Technical Skills & Business Principles
- A critical thinker who possesses logical reasoning
- Curious and always looking for creative solutions to complex problems
Responsibilities
- Define validation Strategy for computerized systems and/or analytical instruments utilized in GxP Space
- Create Validation deliverables such as Validation Plan, Test Protocols, Traceability matrix and execution of protocols
- 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 in US & Canada
- Participate in internal initiatives around Computer Systems Validation
Skills
Computer Systems Validation
GxP
GLP
GMP
21 CFR Part 11
ELN
LIMS
QMS
Validation Plan
Test Protocols
Traceability Matrix
Risk Assessments
Zifo
Specialist scientific informatics services provider
About Zifo
Zifo provides specialized scientific informatics services to organizations focused on innovation in the fields of Laboratory/R&D, Manufacturing, and Trial operations. Their services include Digital Transformation Coaching, Business Analysis, Program & Project Management, Managed Services, Validation, and Custom Development & Integrations. Zifo leverages expertise in areas such as Chem & Bioinformatics, Data Science, Cloud computing, High-Performance Computing (HPC), Instrument Data, MultiOmics, Data Modeling, Semantics, and Artificial Intelligence & Machine Learning (AI&ML) to deliver tailored solutions. Unlike many competitors, Zifo emphasizes a collaborative approach, ensuring that they understand and address the specific needs of their clients in the scientific community. The company's goal is to support its customers in advancing science and technology, ultimately enhancing global health and wellbeing.
None, New YorkHeadquarters
2008Year Founded
GROWTH_EQUITY_NON_VCCompany Stage
Data & Analytics, Biotechnology, HealthcareIndustries
1,001-5,000Employees
Risks
Emerging competition may pressure Zifo's market share and pricing strategies.
Rapid AI advancements may outpace Zifo's current capabilities, requiring continuous R&D investment.
Data privacy issues could arise from handling sensitive client data amid evolving regulations.
Differentiation
Zifo offers specialized scientific informatics services for enterprise laboratories and R&D operations.
The company provides tailored solutions in Chem & Bioinformatics, Data Science, and AI&ML.
Zifo's strategic alliances enhance its capabilities in laboratory digitization and digital transformation.
Upsides
Zifo's Chennai expansion indicates strong growth and increased market share potential.
Recognition in Deloitte Technology Fast 50 India 2023 highlights Zifo's rapid growth and competitiveness.
TA Associates' investment underscores confidence in Zifo's expansion and innovation potential.
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