About us
ALGOTEQUE is an IT consultancy firm that helps startups, mid-sized and large corporations to create and deliver innovative technologies. Our team has a successful track record in designing, developing, implementing, and integrating software solutions (AI, ML, BI, Web, Automation) for Telecom, Energy, Bank, Insurance, Pharma, Automotive, Industry, e-commerce. We deliver our services both in fixed-price and time-and-materials models, helping our customers achieve their business and IT strategies.
Job description
We are looking for a CSV Lead to support validation and compliance activities for computerized manufacturing systems in a regulated pharmaceutical environment. The role focuses on ensuring GxP compliance across projects, validation activities, and manufacturing automation systems.
Responsibilities:
- Provide CSV compliance support for capital and strategic projects.
- Develop, review, and approve validation lifecycle documentation.
- Provide guidance on SDLC, CSA, risk-based validation, qualification, and change control.
- Support validation and qualification activities for manufacturing and laboratory systems.
- Review compliance deliverables and ensure alignment with GxP requirements and internal procedures.
- Support risk assessments, CAPA, change control, and lifecycle compliance activities.
- Ensure systems remain compliant with applicable regulatory and data integrity requirements.
- Collaborate with project, IT, engineering, quality, and manufacturing teams.
Required qualifications
- Hands-on experience in Computer System Validation (CSV) within a GMP-regulated pharmaceutical or manufacturing environment.
- Experience with Validation Lifecycle, CSA, SDLC, IQ/OQ/PQ, Change Control, CAPA, and Risk Management.
- Experience reviewing and approving validation documentation.
- Knowledge of GxP, Data Integrity, FDA/EMA requirements, and pharmaceutical compliance standards.
- Experience supporting computerized manufacturing or laboratory systems.
- Exposure to one or more manufacturing automation platforms including: DeltaV DCS, PLC systems (Rockwell and/or Siemens), Process Historians, Laboratory Automation Systems.
- Strong communication and stakeholder management skills.
- Fluent English.