Job Title: QAV Validation & Digital Specialist
Location: Andover, MA, 01810 (Onsite)
We are seeking a QAV Validation & Digital Specialist to support a strategic quality and digital transformation initiative. This role will initially focus on Quality Assurance Validation activities and will transition into a digital quality-focused function as project needs evolve.
The ideal candidate will bring experience in digital quality systems, electronic documentation management, or manufacturing digitalization initiatives and be willing to learn and support validation processes within a regulated environment. Comprehensive training on company procedures, quality systems, and validation requirements will be provided.
Key Responsibilities
Initial QAV Validation Responsibilities
Review protocols, change controls, SOPs, and validation documentation.
Support compliance assessments and documentation review activities.
Conduct quality reviews to ensure adherence to internal procedures and regulatory requirements.
Participate in validation project execution and documentation management.
Future Digital Quality Responsibilities
Support digital quality initiatives and electronic quality management processes.
Review and manage electronic batch records and associated documentation.
Utilize digital quality platforms and software tools to support quality operations.
Assist with system implementation, optimization, and data-driven quality improvements.
Partner with cross-functional teams to enhance digital workflows and process efficiencies.
Required Qualifications
Bachelor's degree in Engineering, Life Sciences, Information Systems, Computer Science, or a related field.
Experience working with digital quality systems, electronic documentation systems, manufacturing systems, or related digital platforms.
Strong technical aptitude with the ability to learn validation and quality processes.
Excellent organizational, analytical, and communication skills.
Ability to adapt to evolving project requirements and responsibilities.
Preferred Qualifications
Experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
Familiarity with electronic batch records, quality management systems, or validation activities.
Experience supporting digital transformation, process automation, or data management initiatives.
Exposure to systems such as electronic documentation platforms, manufacturing execution systems (MES), or similar quality technologies.
