Jobs at Pinnaql, Inc.

Lead end-to-end peptide process development and scale-up from R&D through first cGMP batches. Define technical direction, select equipment, establish process controls and analytical strategies, drive CMC content for regulatory filings, partner on facility design and commissioning, and build the process development/CMC organization post-Series A. Hands-on leadership with floor-level manufacturing involvement during scale-up and PPQ.

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.

Provide technical engineering support for maintenance, validation, and compliance of utilities, process and cleanroom systems in pharma/biotech. Coordinate training, audits, investigations, regulatory inspection support, and system improvements; ensure cGxP and FDA standards are met.

Lead capital projects for downstream biologics manufacturing from concept through engineering, construction, commissioning, qualification, and validation. Coordinate cross-functional teams, manage scope/schedule/cost/quality, drive capacity expansion, present status and decisions to global engineering leadership, and support risk management and stakeholder communication.

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.

Serve as SME for biologics process design, validate engineering deliverables, act as owner's representative, challenge technical assumptions, support project managers, align design with operations, and reduce execution risk across capital projects.

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.

Lead cross-functional capital, operational, and technical programs in regulated manufacturing. Develop integrated plans, manage schedules/budgets, mitigate risks, align stakeholders, ensure GMP/CQV compliance, govern program reporting, and drive execution with vendors and site teams to deliver projects on time and on budget.

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.

Maintain and forecast integrated Commissioning & Qualification (C&Q) schedules, run scenario and impact analyses, align schedule with document readiness and field execution, support weekly/monthly reporting forums, escalate schedule risks, and coordinate with project integrators and cross-functional leads.

Support and assist execution of periodic reviews for GxP computer systems. Evaluate change controls, deviations, CAPAs, maintenance, access reviews, backups, and audit trails. Compile documentation, apply basic risk-based assessments, ensure Good Documentation Practices, collaborate with QA/IT/Engineering, and support audit/inspection readiness while learning CSV/CSA and GxP compliance.

Lead complex engineering projects across process, manufacturing, utilities, and validation in regulated pharmaceutical/biotech environments. Set engineering policy, develop budgets, coordinate cross-functional teams, support process characterization, scale-up, optimization, and manufacturing support. Serve as technical resource and drive engineering research and novel solutions.

Manage site calibration and metrology operations for pharmaceutical manufacturing, labs, utilities, and facilities. Oversee program performance, KPIs, compliance, staffing, client governance, audits, investigations, and continuous improvement under GMP.

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.

Design, analyze, and implement manufacturing and business process improvements to increase capacity, reduce lead time and WIP, and improve fill rates. Conduct capacity analyses, model processes with simulation and analytical tools, establish KPIs, troubleshoot supply issues, and lead continuous improvement efforts using Lean, Six Sigma, Kaizen, and value stream mapping.

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 commissioning and qualification activities for regulated pharma/biotech projects: develop and execute protocols, perform field execution, support FAT/SAT and startups, document test results, manage deviations and punch-lists, coordinate with engineering/operations/quality/vendors, and ensure GMP and data integrity compliance.

Lead global regulatory strategy and submissions for pharmaceutical products. Prepare and review regulatory documentation, interact with agencies (FDA, EMA), ensure compliance, support post-approval changes, and coordinate cross-functionally on change controls and regulatory impact assessments.

Senior Engineer leads complex engineering and validation projects for pharmaceutical/biotech manufacturing and pilot plants. Responsibilities include process optimization, troubleshooting, design of system modifications, supervising small engineering teams, developing engineering policies, coordinating cross-functional stakeholders, and producing technical and validation documentation.

Lead capital downstream biologics projects through concept, engineering, construction, commissioning, qualification, and validation. Manage scope, schedule, cost, and quality; drive capacity expansions; coordinate cross-functional teams (Engineering, Site Operations, CQV); present status to global leadership; support planning, risk management, and decision-making; work extended hours as needed.