Software Support Engineer
We are seeking a Software Support & Development Engineer to deliver high-quality technical support and build innovative software solutions for the pharmaceutical and biotech industry. This role combines customer engagement and problem resolution with end-to-end software development, including requirement gathering, prototyping, design, coding, testing, documentation, and deployment. The ideal candidate will ensure compliance with quality standards, collaborate closely with product management and cross-functional teams, and drive continuous improvement to enhance both product performance and customer experience.
Key Responsibilities
- Provide technical support to customers regarding quality-related issues in collaboration with the support team. Address inquiries, complaints, and feedback promptly and professionally.
- Investigate and resolve quality issues reported by customers or identified during inspections. Conduct root cause analysis and implement corrective actions to prevent recurrence.
- Maintain detailed records of quality issues, investigations, and resolutions. Prepare reports and documentation for internal and external stakeholders.
- Work closely with cross-functional teams, including Production, Engineering, Service, Support, Sales, Product Management, Product Development, and Customer Service, to address quality concerns and improve product quality.
- Identify opportunities for process improvements and implement changes to enhance product quality and customer satisfaction.
- Provide training and support to customers and internal teams on quality standards, complaint management, and procedures.
- Gather and analyze customer feedback to identify trends and areas for improvement in product quality and service delivery.
- Prepare and present quality reports to management, highlighting key issues, resolutions, and improvement strategies.
- Engage directly with customers to clarify queries, align requirements, and ensure timely resolution of issues.
Qualifications & Requirements
- Education: Bachelor’s degree in Computer Science, Information Technology, Engineering, or related technical discipline.
- Experience: Minimum 3–5 years in software support, complaint management, or quality-related roles, preferably in a regulated industry.
- Technical Competencies:
- Hands-on experience with Azure DevOps (or similar tools) for issue tracking and reporting.
- Strong background in software complaint management processes.
- Proficiency in root cause analysis, conflict analysis, and CAPA implementation.
- Basic knowledge of SQL, scripting, or programming for troubleshooting and data analysis.
- Regulatory & Quality Awareness:
- Familiarity with GMP, 21 CFR Part 11, and ISO quality standards (awareness level sufficient).
- Exposure to pharmaceutical or life sciences regulatory environments is a plus.
- Customer & Collaboration Skills:
- Strong experience in managing customer queries, complaints, and escalations.
- Proven ability to coordinate effectively with internal teams to align on solutions.
- Excellent communication and presentation skills, both written and verbal.
- Soft Skills:
- Analytical and detail-oriented with a problem-solving mindset.
- Adaptable and proactive in managing multiple priorities.
- Customer-first approach with strong interpersonal skills.