Jobs at Pinnaql, Inc.

Serve as the MES subject matter expert for regulated manufacturing operations. Lead PAS-X configuration, implementation, integration, troubleshooting, optimization, upgrades, testing, qualification, validation, and lifecycle support. Support electronic batch records, workflows, recipes, system interfaces, GMP compliance, data integrity, documentation, and root-cause resolution while collaborating with Manufacturing, Automation, Engineering, Quality, IT/OT, and Validation teams.

Supports nonconformance investigations, CAPA execution, root cause analysis, technical report development, mitigation actions, and effectiveness checks in regulated pharmaceutical or medical device manufacturing. Collaborates with SMEs and approvers, participates in CAPA review boards and continuous improvement initiatives, and provides coaching on quality processes while promoting EHS compliance.

Owns assigned construction work packages as the Owner’s field representative, ensuring alignment with safety, quality, schedule, cost, readiness, and turnover objectives. Coordinates Owner, EPCM/construction management, design, CQV, vendors, and contractors; monitors performance; resolves issues; removes constraints; and drives Owner deliverables for equipment, startup, and turnover. The role requires onsite leadership, project controls experience, construction knowledge, quality and commissioning awareness, and coordination across multidisciplinary teams.

Manage controlled pharmaceutical and regulated-manufacturing documents, including SOPs, batch records, protocols, and forms. Maintain version control, coordinate document changes with departments and subject matter experts, and ensure compliance with cGMP, FDA, and EMA requirements. Review and improve document structure, coordinate SOP training, maintain training records, and provide clear proofreading and editing. The role requires bilingual Spanish and English communication and occasional additional work hours.

Provides technical, compliance, investigation, documentation, and change-control support to QA Engineers overseeing pharmaceutical facilities, assets, utilities, maintenance, and qualification activities. Supports utility performance monitoring, root-cause analysis, risk management, quality systems, and compliant technical writing under GDP and data-integrity requirements. Requires engineering education, pharmaceutical GMP experience, familiarity with quality platforms, bilingual English-Spanish communication, and flexibility for 24/7 operations.

Lead or support technical investigations for CQV, cleaning characterization, and sterilization qualification activities in a GMP biologics manufacturing environment. Triage deviations and unexpected results, review protocol and process data, perform root-cause analysis, manage QMS deviation records, recommend CAPA, assess equipment and manufacturing impact, and track investigations through closure while maintaining compliant documentation.

Supervises daily engineering and operational activities in a GMP-regulated environment. Coordinates Engineering, Operations, Maintenance, Quality, contractors, and site personnel; provides technical guidance; supports equipment, utilities, facilities, and operational troubleshooting; ensures safety, GMP compliance, and accurate documentation; participates in deviations, investigations, CAPAs, and change controls; manages priorities, escalations, resources, and continuous improvement initiatives.

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.

Digital Plant Engineer embedded in pharmaceutical automation project teams, aligning manufacturing processes, facility design, automation, MES, historian, PAT, data architecture, and regulatory requirements. Responsibilities include mapping data flows, supporting site-level infrastructure, shaping automation philosophies and digital use cases, coordinating stakeholders, and providing technical consulting. Requires strong pharmaceutical API or bulk manufacturing automation experience, DeltaV Batch DCS, MES, Aveva PI, GMP, and computer system validation knowledge.

Owns and supports aseptic filling equipment and related systems in a pharmaceutical or biotech manufacturing facility. Responsibilities include troubleshooting, investigations, deviations, CAPAs, change controls, maintenance and vendor coordination, equipment qualification, commissioning, startup, documentation review, and GMP compliance. The role serves as the primary technical contact for vial, syringe, and isolator-based filling systems while collaborating with Engineering, Manufacturing, Maintenance, Automation, Quality, and Validation teams.

Leads manufacturing engineering operations, technical projects, process improvement, and validation activities. Provides mentorship to associate engineers and COOP students, develops and executes IQ/OQ/PQ protocols, applies statistical analysis, resolves complex manufacturing challenges, and ensures GMP, quality, and compliance standards are met while improving operational efficiency.

Leads the Quality organization for a 503B outsourcing facility, overseeing the QMS, QA, QC, regulatory compliance, inspections, audits, deviations, CAPA, validation, documentation, laboratory activities, product disposition, and continuous improvement. Partners cross-functionally to ensure cGMP, USP, FDA, and pharmacy-regulatory compliance while protecting product quality and patient safety. Manages quality personnel and supports operational growth, inspection readiness, complaints, recalls, and regulatory reporting.

Leads commissioning and qualification strategy, risk assessments, FAT/SAT, field commissioning, and IQ/OQ/PQ execution for pharmaceutical and biotech systems. Develops protocols, ensures GMP and data integrity compliance, manages change controls, deviations, and CAPAs, and prepares validation reports. Coordinates with engineering, quality, manufacturing, supply chain, vendors, and contractors while mentoring engineers. Also develops and executes characterization protocols, supports project planning, and provides advanced engineering solutions for complex facility and equipment projects.

Lead end-to-end project delivery in a structured PMO environment, managing scope, schedules, budgets, risks, dependencies, change control, governance, documentation, and KPI reporting. Coordinate cross-functional teams in matrixed organizations, resolve roadblocks, maintain stakeholder alignment, and improve project delivery processes using standardized methodologies and tools.

Lead multiple pharmaceutical packaging equipment and capital projects from planning through installation, commissioning, qualification, operational handoff, and closeout. Manage scope, schedules, budgets, risks, resources, vendors, contractors, and cross-functional teams. Coordinate GMP, validation, quality, safety, documentation, FAT/SAT, IQ/OQ/PQ, change control, and production readiness activities. Facilitate governance meetings, track issues and decisions, communicate status to stakeholders, and drive timely project delivery and closeout.

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 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.

Leads onsite engineering activities at an FDA-regulated manufacturing facility, coordinating CQV, automation, process, facilities, maintenance, quality, and operations teams. Drives project execution, schedules, technical issue resolution, equipment installation and startup, qualification, troubleshooting, upgrades, and continuous improvement. Ensures compliance with GMP, safety, quality, and site requirements while communicating priorities, risks, and project status to stakeholders.

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.

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.