Job Description

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.