Validation Engineer

Validation Engineer

Location:

WALTHAM, MA (Onsite) Exp need –10+ years

• Expand the laboratory systems stack knowledge and understand local laboratory procedures.
• Support and configure laboratory equipment inside Empower and other systems to ensure correct execution of laboratory testings.
• Accurately translate business processes into technical terms and vice versa
• Build and maintain awareness and knowledge of regulatory, legal, or quality requirements impacting the quality control laboratory, and ensure that solution requirements comply
• Deliver and support laboratory systems stack to start up new quality control lab operations inside the concord site.
• Work with global system teams to ensure operational readiness of laboratory systems to support the operational objectives of the concord facility (i.e. validation plans, standard operating procedures, training, etc.)
• Produce and maintain project and validation documentation
• Ensure systems remain in a validated state and manage their lifecycle through releases, recapitalization, and retirement
• Ensure the incident, problem, configuration, and change/release management are all accomplished in alignment with and understanding of business need
• To have good experience on e3a and e3b instruments and Lab systems.

• Prior work experience working in pharma or other GMP setting
• Strong working knowledge of quality control laboratory IDS systems
• Solid knowledge of Computer System Validation process
  · Demonstrated ability to analyze, anticipate, and resolve complex issues (technical, operational, or business-related) through sound problem-solving skills
• Effectively prioritize and escalate issues
• Demonstrated learning agility and curiosity
• Demonstrated ability to understand quality control business processes and convert into IT requirements/solutions
• Desire and ability to communicate using a variety of methods in diverse forums

• Resource should be quick learner and self-driven; capable of working with client partners to meet strategic Objectives
• Resource must be able to identify, mentor and hone talent to build leaders from within a team.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.