8 jobs in Harba

Key Responsibilities

• Provide technical leadership and process engineering support for aseptic fill-finish manufacturing operations within a GMP-regulated pharmaceutical environment
• Support filling, compounding, formulation, and sterile processing operations to ensure reliable and compliant manufacturing performance
• Lead process optimization, troubleshooting, and continuous improvement initiatives focused on fill-finish equipment, aseptic processes, and manufacturing efficiency
• Partner cross-functionally with Manufacturing, Quality, Validation, Maintenance, Engineering, and Technical Operations teams to support production goals and operational readiness
• Support investigations, root cause analysis, CAPAs, deviations, and change control activities related to fill-finish manufacturing processes and equipment
• Develop and revise SOPs, batch records, engineering documentation, and technical reports to support manufacturing and compliance activities
• Assist with equipment qualification, process validation, media fills, and technology transfer activities for aseptic manufacturing systems
• Monitor process performance data and identify opportunities to improve throughput, reduce downtime, and enhance process robustness
• Provide engineering oversight for filling lines, isolators, sterilization systems, single-use technologies, and other fill-finish equipment
• Support commissioning, startup, and implementation of new manufacturing equipment and process improvements within sterile production environments
• Collaborate with site leadership and operational teams to ensure manufacturing activities align with safety, quality, and production objectives
• Participate in audits, regulatory inspections, and compliance readiness activities related to aseptic processing and fill-finish operations

Qualifications

• 5+ years of process engineering experience within pharmaceutical, biotech, or other GMP-regulated manufacturing environments
• Hands-on experience supporting aseptic fill-finish, sterile manufacturing, or injectable drug product operations required
• Strong knowledge of aseptic processing, sterile techniques, GMP compliance, and pharmaceutical manufacturing standards
• Experience supporting filling equipment, isolators, autoclaves, CIP/SIP systems, formulation equipment, or other sterile manufacturing technologies preferred
• Demonstrated experience leading process improvements, equipment troubleshooting, investigations, and manufacturing support activities
• Familiarity with validation lifecycle activities including IQ/OQ/PQ, process validation, and media fill execution preferred
• Strong technical writing and documentation skills with experience authoring SOPs, deviations, CAPAs, change controls, and engineering reports
• Ability to work cross-functionally in a fast-paced manufacturing environment while managing multiple priorities and deadlines
• Experience utilizing data analysis and process monitoring tools to support operational performance and continuous improvement initiatives
• Lean Manufacturing, Six Sigma, or other continuous improvement experience is a plus
• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field preferred

Job Requirements

• Design, build, and own large-scale data pipelines, ETL/ELT workflows, and data warehouse architecture (primarily AWS and Snowflake)
• Lead dbt implementation including modeling conventions, testing frameworks, and documentation standards
• Architect and deliver high-performance Python APIs and microservices connecting the data platform to downstream applications
• Build backend services supporting both real-time and batch access patterns
• Design and manage production data workflows across AWS, Kubernetes, Docker, and Airflow using infrastructure-as-code (Terraform/CloudFormation)
• Establish and enforce data quality, governance, and coding standards across internal and external data products
• Lead AI/LLM-enabled data access initiatives to make complex datasets more discoverable and usable
• Drive cross-functional, multi-team data initiatives from architecture through production delivery
• Serve as the senior technical voice on platform strategy, observability, and infrastructure decisions
• Mentor engineers and potentially carry direct management responsibilities

Job Qualifications

Required

• 10+ years of experience in data or software engineering with a proven track record on production-grade systems at scale
• Expert-level SQL — complex transformations, query tuning, and performance optimization
• Expert Python skills — ETL/ELT frameworks, FastAPI or Flask, clean modular code
• Proven dbt architecture experience — advanced modeling, testing, and documentation
• Deep hands-on experience with a cloud data warehouse (Snowflake, BigQuery, or Redshift), including security and performance tuning
• Production pipeline orchestration experience using Airflow, Dagster, or equivalent
• Core engineering fundamentals: system design, Git, CI/CD, Docker, Terraform
• Solid AWS experience: S3, IAM, API integrations, security configuration
• Strong communication and technical leadership skills in ambiguous, fast-paced environments

Preferred

• Experience with biological or bioinformatics data (PCR, genomic sequencing, wastewater surveillance) or working alongside lab teams
• Snowflake production ownership: RBAC, authentication patterns, cost controls
• Observability stack experience: Grafana, Datadog, or similar
• Experience with data ingestion tooling: Airbyte, Fivetran, or custom solutions
• Data governance and cataloging exposure
• BI tool data modeling experience (Tableau, Looker, Metabase)
• Kubernetes familiarity for container orchestration
• Comfort with AI-assisted development tools (Copilot, Cursor)

Job Requirements

• Design, build, and own large-scale data pipelines, ETL/ELT workflows, and data warehouse architecture (primarily AWS and Snowflake)
• Lead dbt implementation including modeling conventions, testing frameworks, and documentation standards
• Architect and deliver high-performance Python APIs and microservices connecting the data platform to downstream applications
• Build backend services supporting both real‑time and batch access patterns
• Design and manage production data workflows across AWS, Kubernetes, Docker, and Airflow using infrastructure‑as‑code (Terraform/CloudFormation)
• Establish and enforce data quality, governance, and coding standards across internal and external data products
• Lead AI/LLM‑enabled data access initiatives to make complex datasets more discoverable and usable
• Drive cross‑functional, multi‑team data initiatives from architecture through production delivery
• Serve as the senior technical voice on platform strategy, observability, and infrastructure decisions
• Mentor engineers and potentially carry direct management responsibilities

• 10+ years of experience in data or software engineering with a proven track record on production‑grade systems at scale
• Expert‑level SQL — complex transformations, query tuning, and performance optimization
• Expert Python skills — ETL/ELT frameworks, FastAPI or Flask, clean modular code
• Proven dbt architecture experience — advanced modeling, testing, and documentation
• Deep hands‑on experience with a cloud data warehouse (Snowflake, BigQuery, or Redshift), including security and performance tuning
• Production pipeline orchestration experience using Airflow, Dagster, or equivalent
• Core engineering fundamentals: system design, Git, CI/CD, Docker, Terraform
• Solid AWS experience: S3, IAM, API integrations, security configuration
• Strong communication and technical leadership skills in ambiguous, fast‑paced environments

• Experience with biological or bioinformatics data (PCR, genomic sequencing, wastewater surveillance) or working alongside lab teams
• Snowflake production ownership: RBAC, authentication patterns, cost controls
• Observability stack experience: Grafana, Datadog, or similar
• Experience with data ingestion tooling: Airbyte, Fivetran, or custom solutions
• Data governance and cataloging exposure
• BI tool data modeling experience (Tableau, Looker, Metabase)
• Kubernetes familiarity for container orchestration
• Comfort with AI-assisted development tools (Copilot, Cursor)

Responsibilities

• Lead and manage internal, supplier, client, and regulatory audit programs across GMP manufacturing operations
• Serve as the primary point of contact during FDA, EMA, and other global regulatory inspections
• Coordinate audit preparation activities, back‑room support, responses to observations, and CAPA implementation efforts
• Build, mentor, and develop high‑performing Quality and Supplier Quality teams within a fast‑paced manufacturing environment
• Drive strategic workforce planning, succession planning, and technical capability development across the Quality organization
• Oversee supplier qualification programs, including risk assessments, vendor onboarding, supplier performance monitoring, and ongoing compliance activities
• Plan and conduct supplier audits, including pre‑qualification, surveillance, and for‑cause audits across raw materials, components, and contract service providers
• Partner closely with Manufacturing, Supply Chain, Engineering, Validation, and Technical Operations teams to support operational excellence initiatives
• Manage supplier changes and associated quality risk assessments to minimize supply chain disruptions and maintain regulatory compliance
• Support development and continuous improvement of quality systems, audit programs, and inspection readiness strategies
• Develop training programs and strengthen technical expertise related to sterile manufacturing, aseptic processing, and pharmaceutical quality systems
• Drive continuous improvement initiatives focused on compliance, efficiency, quality culture, and long‑term operational scalability

• 8–10+ years of experience within pharmaceutical, biotech, biologics, or other highly regulated GMP manufacturing environments
• Strong background in Quality Assurance, supplier quality management, auditing, and regulatory compliance
• 5+ years of leadership experience managing, mentoring, and developing Quality professionals
• Experience supporting FDA, EMA, MHRA, or other global regulatory inspections and client audits
• Strong understanding of supplier qualification, vendor oversight, deviations, CAPAs, change controls, and risk management methodologies
• Experience within sterile manufacturing, aseptic processing, injectable products, biologics, or parenteral manufacturing environments preferred
• Familiarity with validation principles, data integrity expectations, and pharmaceutical quality systems
• Lean Six Sigma, ASQ certifications, or other continuous improvement experience is a plus
• Excellent communication and leadership skills with the ability to interact effectively with executive leadership, regulatory agencies, suppliers, and cross‑functional stakeholders

Harba is seeking a Quality Assurance Manager to lead and manage audit programs for GMP manufacturing operations in Indianapolis. The role involves coordinating regulatory inspections and building high-performing Quality teams in a fast-paced environment.

The ideal candidate has over 8 years of experience in pharmaceutical manufacturing, strong leadership skills, and a deep understanding of regulatory compliance. This position offers competitive remuneration and the opportunity to drive continuous improvements.

Harba, located in Boston, Massachusetts, is seeking a Senior Full Stack Software Engineer who will be responsible for building production-grade software that supports biosecurity, epidemiology, and biological data workflows. This role involves working with backend services, data pipelines, and modern web applications, and requires close collaboration with domain experts.

The ideal candidate will have 6-8+ years of experience, strong proficiency in Python, and expertise in modern JavaScript frameworks like React. This position offers the opportunity to contribute to scalable and reliable systems that serve U.S. Government customers.

Job Overview

This role is for a Senior Full Stack Software Engineer focused on building production‑grade software that supports biosecurity, epidemiology, and biological data workflows. The position involves working across backend services, data pipelines, and modern web applications to transform complex biological data into actionable insights. The ideal candidate thrives in cross‑disciplinary environments and contributes to scalable, secure, and reliable systems. This role requires collaboration with domain experts and supports work related to U.S. Government customers, including eligibility for a U.S. security clearance.

• Develop full stack applications that translate complex biological and operational data into intuitive software solutions using Python and modern JavaScript frameworks
• Build and maintain backend services, APIs (REST and/or GraphQL), and data pipelines supporting biological datasets such as genomic, diagnostic, or epidemiological data
• Collaborate with scientific, operational, and product domain experts to translate requirements into robust software systems and actionable insights
• Design, implement, and maintain scalable CI/CD pipelines with automated unit, integration, and security testing as deployment gates
• Leverage AI‑assisted development tools (such as generative AI and LLM‑based assistants) to improve development speed, code quality, and automation of routine tasks
• Participate in technical design reviews and contribute to architectural decisions, system modularity, and long‑term platform evolution
• Monitor, troubleshoot, and support production systems, including participation in on‑call rotations and incident response when needed
• Identify and address technical debt and architectural bottlenecks to improve system reliability and maintainability
• Ensure high standards for data integrity, provenance, observability, and security across all systems and workflows
• Contribute to a culture of engineering excellence, documentation, and deployment confidence

• 6-8+ years of professional software engineering experience with significant full stack development responsibilities
• Strong proficiency in Python for backend development
• Experience building and consuming REST and/or GraphQL APIs
• Experience with modern frontend development using JavaScript or TypeScript and frameworks such as React
• Experience integrating AI‑assisted development tools into daily engineering workflows
• Strong understanding of software engineering fundamentals including data structures, system design, version control, and CI/CD practices
• Experience collaborating with non‑engineering domain experts to translate complex data into software solutions (biological, scientific, or similar domains preferred)
• Familiarity with cloud infrastructure, containerization, or regulated or sensitive data environments is a plus