Jobs at Pinnaql, Inc.

Senior engineer to lead process optimization, troubleshooting, design and implementation of complex manufacturing and capital projects in regulated pharmaceutical/biotech environments. Oversees small teams, develops procedures, coordinates cross-functional stakeholders, supports validation, ensures equipment reliability, and drives continuous improvement and compliance.

Lead engineering efforts for process optimization, troubleshooting, design and implementation of major system modifications and capital projects in pharmaceutical/biotech manufacturing. Supervise small engineering teams, coordinate cross-functional stakeholders, develop procedures and budgets, and ensure validation, GMP/GLP compliance, equipment reliability, and continuous improvement.

Provide EHS oversight for construction in active biotech/GMP facilities: conduct inspections, review JHAs and work permits, monitor high-risk activities, onboard contractors, support incident investigations, track safety KPIs, and ensure environmental compliance for utilities and process waste systems.

Lead planning, execution, tracking, and closeout of regulated pharmaceutical projects. Maintain schedules, dashboards, documentation, and risks. Coordinate cross-functional teams, vendors, and stakeholders; drive resource planning, change management, and timely resolution of issues.

Lead and deliver manufacturing projects for liquid mixing, blending, filling, and packaging. Plan schedules, budgets, resources, and risk mitigation. Coordinate cross-functional teams, manage contractors and vendors, support equipment installation/commissioning, and ensure safety, quality, and food manufacturing compliance while driving process optimization and production transfers.

Maintain and improve the quality system for referral management, call center, and fulfillment operations. Monitor regulatory compliance, analyze quality metrics, conduct investigations, support corrective actions, run audits, prepare reports, and participate in quality improvement to ensure customer satisfaction.

Serve as technical specialist for molecular biology and microbiology testing and assay development/validation. Provide technical guidance, troubleshoot assays, ensure GMP/GLP compliance, develop and audit controlled documents, lead investigations and audits, interact with regulators, manage multi-site programs, and support training and project work.

Coordinate and manage engineering drawing revisions, approvals, and documentation control within regulated pharmaceutical/biotech capital projects. Support CAD drafting, maintain archives per site procedures, ensure compliance with drawing management systems, and liaise with site personnel, project teams, and clients to meet dynamic project schedules.

Provide technical support across the project lifecycle for pharmaceutical manufacturing: equipment assessment, capital project development, design review, installation support, verification (CQV), change controls, investigations, process improvements, and stakeholder coordination in GMP-regulated environments.

Lead process development for sterile drug products: design and run experiments, process characterization, validation (PPQ), tech transfer, data analysis, and commercial process support while authoring protocols, reports, and driving cross-functional improvements.

Lead design, execution, and analysis of process development experiments in regulated industries. Develop protocols, introduce technologies, author technical documents, mentor staff, and drive projects to meet milestones and regulatory expectations.

Support quality and compliance activities for capital projects in regulated pharma/biotech manufacturing, including investigations, CAPA, change control, GMP documentation review, compliance tracking, onboarding coordination, and cross-functional communication to ensure alignment with GMP and site procedures.

Lead development, implementation, and continuous improvement of Environmental Health & Safety programs. Ensure regulatory compliance, perform audits/inspections, interface with agencies, conduct risk assessments, and develop training, procedures, and corrective actions to manage process safety and operational EH&S risks.

Provide QA oversight for pharmaceutical drug substance manufacturing under cGMP/cGLP: approve protocols/reports, lead investigations and audits, manage change controls/CAPA, authorize lot dispositions, support NPI, CSV, automation, facilities, and environmental programs, and act as Quality Unit representative.

Serve as the primary coordination interface for a portfolio of regulated capital projects, supporting resource allocation, contract administration, communication, issue escalation, documentation tracking, reporting, and operational alignment across cross-functional teams in pharmaceutical and biotech manufacturing environments.

Support EHSS activities for capital projects and construction in regulated pharmaceutical and biotechnology manufacturing. Coordinate safety permits, contractor compliance, inspections, hazard identification, incident investigations, toolbox talks, EHSS metrics tracking, environmental compliance, and communication with project teams to ensure safe project execution and regulatory alignment.

Support execution of capital projects in FDA-regulated manufacturing: coordinate engineering deliverables, vendor/contractor interfaces, installation, startup/commissioning, documentation, GMP compliance, and cross-functional technical activities to achieve operational handover.

Lead and deliver manufacturing projects (commissioning & qualification, capital, construction, NPI, expansions). Develop plans, manage teams, control budget/schedule, mitigate risks, ensure compliance, and communicate with stakeholders. Available for extended hours and occasional weekends/holidays.

Lead characterization, process optimization, and troubleshooting for manufacturing/pilot plant or capital projects. Design and implement major system modifications, develop and execute validation protocols (IQ/OQ/PQ), perform FAT/SAT, generate deviations and reports, and present results to support regulatory compliance in pharma/biotech environments.

Lead ETL engineering activities for pharmaceutical/biotech projects including design planning, standards compliance, vendor liaison, RFIs/submittals, change management, FAT planning, design qualification reports, and support for commissioning and site change control. Ensure cGxP, EHSS, and Factory Mutual considerations are integrated and track design progress against project schedules.