Discover the Vimachem Pharma MES Platform
CSV & Equipment Validation Consultant at Vimachem
// Vimachem
The Company
Vimachem is a global provider of Pharma 4.0 software and hardware solutions focusing in the pharmaceutical industry. Vimachem headquarters are in Athens, Greece and our US office is based in New York City. Our clientele includes some of the largest pharmaceutical companies in Europe and USA. Our productized services philosophy combines innovative solutions with specialized consulting services that support our pharmaceutical customers in their digital transformation journey and in achieving operational efficiencies and business excellence.
The Culture
At Vimachem we firmly believe that the strength of the team is each individual member and that the strength of each member is the team.
We are only as brilliant and impactful as the people on our team, so we make building a strong culture and rewarding success among our highest priorities. In addition to great environment we invest heavily in training and career mobility.
Vimachem promotes open collaboration and value through innovation.
Are you ready for your next challenge? Join our team of restless disrupters and challenge seekers that are leading the change in our industry.
The Opportunity:
We are currently seeking a Validation Lead consultant to provide validation expertise to new and existing clients.
The successful candidate will conduct, provide oversight and support packaging validations and validation/verification of computer systems and industrial equipment. This role will also be responsible to setup and manage the Validation team of Vimachem.
Responsibilities include: Design, develop and execute test scripts from software requirements for computer system validation.
Generate, execute, review and complete validation documentation required, such as Traceability Matrix, URS, IQ/OQ/PQ protocols and summary reports.
Demonstrate solid understanding of the EU and FDA validation guidelines and industry best practices.
Implement policies and procedures to validate / qualify equipment, computer systems, and processes in accordance with regulatory requirements and company standards.
Coordinate, direct and lead validation efforts, including equipment, process, and computer system validation.
Compile and analyze validation data and maintain validation documentation.
Facilitate and/or support validation training, change control, periodic review of validated systems, equipment and processes.
Interface with management personnel to represent QA/Validation in project teams, with the objective to assure that project quality objectives are met.
Provide technical decision-making regarding cGMP compliance, regulatory issues, validation strategy and quality systems and/or strategic activities.
Conduct root cause analysis prepare technical investigative reports and formulate recommendations for disposition and actions related to product non-conformance.
The successful candidate will conduct, provide oversight and support packaging validations and validation/verification of computer systems and industrial equipment. This role will also be responsible to setup and manage the Validation team of Vimachem.
Responsibilities include:
Skills and Requirements
- BS degree is required. Degree in a technical discipline is preferred.
- 3+ years of experience in highly regulated environment (Medical device, pharmaceutical, etc.) is required.
- Strong validation skills with demonstrated knowledge within the areas of computer system / equipment / process validations and quality assurance.
- In-depth understanding of cGMPs, ISO 13485, GAMP, EU Annex 11, 21 CFR Part 11 and current industry / EU / FDA compliance.
- Excellent communication (verbal and written), teamwork and organizational skills.
- Fluency in English is required. German or Spanish language skills are a plus.
- Ability to develop and meet project schedules, along with contingency plans.
If you’re looking to join an exciting, fast-moving company that is at the center of revolutionizing the Life Sciences industry, Vimachem wants to talk to you.