Intellectt Inc

Compensation

Full Description

Hiring for Process Engineer in Albany NY - Onsite Industry: Biotech / Pharmaceutical Manufacturing Position Summary CM is seeking a skilled contractor to support documentation standardization and workflow automation initiatives within the Process Sciences team. This role will focus on consolidating technical data, developing standardized templates, and automating reporting workflows to support process validation, tech transfer, and regulatory compliance across internal and CMO operations. Key Responsibilities • Develop and standardize process documentation templates (IPC, PCS, validation reports) • Automate data consolidation and reporting workflows using Python, Power Apps, or similar tools • Support tech transfer and process validation activities • Review and harmonize external CMO documentation and data • Centralize and manage historical and current process data, including: • Process parameters • IPC criticality rationale • Process characterization data • Collaborate with QA, Validation, Regulatory, and CMO partners • Support regulatory documentation and compliance efforts Qualifications • 5+ years of experience in QA, Validation, Process Development, or Compliance (biotech/pharma preferred) • Strong understanding of GMP, SOPs, tech transfer, and process validation • Experience with document control systems and workflow automation tools (Python, Power Apps) • Experience working with CMOs and regulatory documentation (preferred)