Stark Pharma Solutions Inc

About the Company

Established in 2014, Stark Pharma is a trusted consulting service partner for pharmaceutical, medical device, biotech, and IT clients. With direct operations in USA, Canada, and India, we bring a wealth of expertise and tailored solutions to help our clients achieve their strategic goals. Our Services: 1. Pharma, Medical Device & Biotech Consulting: We specialize in delivering expert guidance across: * Design & R&D * Formulation Development * Analytical R&D * Regulatory Affairs * Validation & Quality Assurance * Manufacturing Operations * Supply Chain Management * Project Management 2. IT Consulting: Our technology solutions empower IT clients to stay ahead in a competitive digital landscape: * Software Development & Testing * Generative AI & Machine Learning * Networking Solutions * Cloud Technologies 3. Staffing & Recruitment Services: We bridge talent gaps by providing contract and full-time staffing solutions for: * Pharma, Biotech, and Medical Device industries * IT roles across software, cloud, and emerging technologies Why Choose Stark Pharma? * Industry Expertise: Our deep domain knowledge ensures practical, impactful solutions. * Global Reach: Operating across the USA, Canada, and India, we understand diverse market needs. * Tailored Solutions: From consulting to staffing, our approach is customized to fit your unique requirements. * Commitment to Excellence: We are driven by a passion for quality, innovation, and client success. Our Mission To empower our clients with innovative consulting and staffing solutions that drive growth, operational excellence, and long-term success. Partner with Stark Pharma to take your business to the next level. Together, we can shape a brighter future in healthcare and technology.

Listed Jobs

Company Name

Stark Pharma Solutions Inc

Job Title

CSV Quality Assurance Engineer

Job Description

**Job title:** CSV Quality Assurance Engineer **Role Summary:** Provide quality assurance oversight for ERP systems and related applications in a pharmaceutical manufacturing environment, ensuring alignment with corporate CSV standards, GxP regulations, and industry best practices. **Expactations:** * 7‑12 years of professional experience in IT CSV and QA within the pharmaceutical sector. * Proven ability to manage validation documentation, audits, inspections, and issue tracking. * Strong collaboration skills with IT, QA, and business stakeholders. **Key Responsibilities:** 1. Oversee quality assurance for ERP systems and associated applications. 2. Ensure compliance with corporate CSV standards, GxP regulations, and industry best practices. 3. Review, approve, and support validation documentation (plans, test scripts, reports). 4. Collaborate with IT, QA, and business stakeholders to guarantee system readiness and compliance. 5. Support audits, inspections, and internal assessments related to IT systems. 6. Track and manage issues using ServiceNow, JIRA, and HP ALM. **Required Skills:** * Strong expertise in IT Computer System Validation (CSV). * Hands‑on experience in IT Quality Assurance and eCompliance management. * Proficiency with Veeva Quality Docs, ServiceNow, JIRA, and HP ALM. * In-depth knowledge of GxP regulations and pharmaceutical industry practices. * Excellent documentation, communication, and issue‑resolution skills. **Required Education & Certifications:** Not specified. (Professional experience requirement implies a senior‑level qualification.)

Indiana, United states

Hybrid

Senior

19-09-2025

Company Name

Stark Pharma Solutions Inc

Job Title

Process Development Engineer

Job Description

**Job Title:** Process Development Engineer **Role Summary:** Develop and validate manufacturing processes for medical devices in plastic injection molding, ensuring compliance with regulatory standards. **Expectations:** Requires a detail-oriented engineer with 3+ years of medical device industry experience, expertise in process optimization, validation, statistical analysis, and cross-functional collaboration. **Key Responsibilities:** - Lead plastic injection molding process development, validation, and troubleshooting. - Execute Test Method Validation (TMV) protocols, data analysis, and documentation. - Apply statistical tools (DOE, SPC, GR&R) in Minitab for process validation and improvement. - Collaborate with R&D, Quality, Manufacturing, and Supply Chain teams. - Conduct DFM reviews and support product design transfers. - Develop IQ/OQ/PQ protocols for equipment, tooling, and processes. - Perform root cause analysis and implement CAPA for process deviations. - Maintain compliance with FDA, ISO 13485, and GMP regulations. - Prepare technical reports and validation documentation for audits. - Advise suppliers on tooling, material selection, and process improvements. **Required Skills:** - Plastic injection molding process development and troubleshooting. - Test Method Validation (TMV) experience. - Proficiency in Minitab for DOE, SPC, GR&R, and process capability analysis. - Regulatory compliance knowledge (FDA, ISO 13485, GMP). - IQ/OQ/PQ protocol execution. - Cross-functional teamwork and problem-solving abilities. **Required Education & Certifications:** - Bachelor’s degree in Engineering or related field. - 3+ years of medical device industry experience (plastics injection molding). - GMP and validation protocol knowledge.

Minnesota, United states

On site

Junior

04-10-2025

Company Name

Stark Pharma Solutions Inc

Job Title

Bioinformatics Data Scientist

Job Description

Job Title: Bioinformatics Data Scientist Role Summary: Develop a GEO‑like data management platform to ingest, curate, store, and expose large‑scale omics datasets (bulk/single‑cell RNA‑seq, spatial omics, CyTOF) for internal research reuse. Expectations: 5+ years of experience in bioinformatics/data engineering; strong programming (Python, R, SQL); proven track record with omics pipelines; knowledge of FAIR principles, metadata standards, and data governance; ability to collaborate with cross‑functional teams. Key Responsibilities: - Design and implement scalable data pipelines for omics data ingestion, curation, and storage (PostgreSQL, MongoDB). - Build and maintain a web‑based catalog/portal for dataset discovery, metadata visualization, and QC metrics. - Define and enforce metadata standards, ontologies, and schemas to ensure consistency and interoperability. - Implement access controls and permission systems for data security and compliance. - Integrate the system with existing compute and storage infrastructures (AWS, GCP, HPC). - Process raw data and manage large‑scale biological datasets for internal use. Required Skills: - Advanced programming in Python, R, and SQL (PostgreSQL). - Hands‑on experience with omics data pipelines (bioinformatics tools, workflow orchestrators). - Familiarity with metadata models, data provenance, FAIR data principles, and biological ontologies. - Knowledge of relational and NoSQL databases. - Proficiency with Git and version control. - Strong communication and teamwork skills. Required Education & Certifications: - Bachelor of Science in Bioinformatics, Computational Biology, Data Science, Computer Science, or related field (minimum 5 years experience) OR Master’s degree in the same fields with 0–3 years experience. - Certifications in data engineering, cloud platforms, or bioinformatics (preferred but not mandatory).

Massachusetts, United states

Hybrid

Mid level

17-10-2025

Company Name

Stark Pharma Solutions Inc

Job Title

Data Integration Scientist

Job Description

Job title: Data Integration Scientist Role Summary: Design and build a scalable, central data management system for large‑scale omics datasets, enabling ingestion, curation, storage, discovery, and reuse across research teams. Expactations: Deliver end‑to‑end data pipelines, metadata standards, and a web portal; ensure data governance, security, and compliance; collaborate with IT, research, and cross‑functional stakeholders. Key Responsibilities: - Architect and implement scalable ingestion, curation, and storage pipelines for bulk/single‑cell RNA‑seq, spatial omics, CyTOF, etc. - Build and maintain a web‑based data catalog/portal (e.g., R‑Shiny) for dataset discovery, metadata browsing, and QC visualization. - Define and enforce metadata schemas, ontologies, and FAIR principles to guarantee consistency and interoperability. - Implement access controls, permission systems, and security measures aligned with compliance standards. - Integrate the system with existing compute and storage infrastructures (cloud/HPC). - Process and organize raw biological data for internal use. - Version control code and pipelines using Git; maintain CI/CD practices for pipeline updates. Required Skills: - Proficiency in Python, R, and SQL/PostgreSQL (and familiarity with MongoDB). - Hands‑on experience building and maintaining bioinformatics data pipelines (Nextflow, Snakemake). - Knowledge of metadata models, data provenance, and FAIR data principles. - Ability to develop web applications or dashboards (R‑Shiny). - Experience with cloud or HPC environments (AWS, GCP, on‑prem). - Strong collaboration skills across cross‑functional teams. Required Education & Certifications: - BS (≥5 years experience) or MS (≤3 years experience) in Bioinformatics, Computational Biology, Data Science, Computer Science, or related field. - Relevant certifications in data engineering, cloud services, or bioinformatics tools are advantageous but not mandatory.

Massachusetts, United states

Hybrid

Mid level

17-10-2025