Jobs at Pinnaql, Inc.

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.

Provides scientific, operational, and compliance support for sterile and non-sterile pharmaceutical manufacturing investigations. Leads Quality Event, CAPA, NTR, and NOE completion, closure, and trend evaluations; supports regulatory submissions and inspections; analyzes statistical data; and coordinates corrective actions to prevent recurrence. Requires pharmaceutical manufacturing experience, investigation expertise, cGMP and regulatory knowledge, strong technical communication, Microsoft Office proficiency, and bilingual Spanish-English communication skills.

Lead capital and expense engineering projects for a GMP-regulated pharmaceutical site. Coordinate engineering, operations, maintenance, quality, and validation activities from concept through commissioning, ensuring compliance with GMP, equipment qualification (IQ/OQ/PQ), safety, budgets, and schedules. Manage contractors, vendors, CAPEX, and cross-functional priorities while supporting continuous improvement, reliability, and project turnover to operations.

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.

Implements and maintains pharmaceutical quality systems while supporting manufacturing operations, investigations, CAPA, product impact assessments, risk evaluations, and product disposition. Reviews and approves SOPs, change controls, validation and calibration documentation, and ensures compliance with GMP, regulatory, and EHS requirements. Supports audits, new product introductions, quality initiatives, and manufacturing oversight. Serves as backup to the QA Manager and collaborates with plant and quality departments.

Performs microbiological testing of water, raw materials, in-process samples, and finished pharmaceutical products, including bioburden and endotoxin testing. Conducts environmental, gowning, and surface monitoring using established procedures and regulatory standards. Documents results, maintains laboratory equipment and supplies, manages sample collection and waste disposal, supports manufacturing during filling, and follows cGMP, GLP, safety, and EH&S requirements. The role requires rotating shifts, weekend and holiday availability, and possible overtime.

Manage pharmaceutical and biotechnology quality systems, including nonconformances, CAPA, change control, and risk management. Monitor KPIs, facilitate quality review meetings, ensure investigations reach root cause, verify corrective action effectiveness, maintain tracking databases, and perform statistical trend analysis of deviations and exception records. Support annual quality reviews and identify trends requiring manufacturing or control procedure changes.

Lead automation projects for design, implementation, testing, commissioning, validation support, and closeout in a GMP-regulated manufacturing environment. Coordinate system integration, PLC and BMS/Zenon/EMS modifications and migrations, manage schedules, risks, outages, and stakeholder/vendor coordination while ensuring compliance with safety, quality, and site procedures.

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.

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.

Performs plant quality assurance oversight for cGMP manufacturing, including batch record review, deviations, CAPAs, change control, audits, validations, and quality systems. Supports computer systems validation, commissioning and qualification, new product introduction, regulatory inspections, and continuous improvement. Collaborates across manufacturing, engineering, validation, quality control, facilities, and other functions while advising management on quality and compliance risks. Requires strong organizational, project management, communication, data trending, and regulatory interaction skills in English and Spanish.

Manages document control and periodic reviews of training systems in a GxP-regulated pharmaceutical environment. Collaborates with subject matter experts and trainers to create, update, coordinate, and implement training content. Supports learning transactions in SuccessFactors and ServiceNow, facilitates operational learning, and ensures compliance with GMP procedures. The role requires strong organization, communication, presentation, compliance judgment, and the ability to manage competing priorities across a complex matrix organization.

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.

Develop and execute packaging and material characterization studies, define equipment operational parameters, apply DOE and statistical analysis, perform edge-of-failure testing, document results, and collaborate with engineering, quality, and manufacturing to optimize packaging performance and ensure regulatory compliance.

Provide engineering support for process optimization, troubleshooting, and minor design projects in manufacturing/pilot plant environments. Apply standard engineering techniques, audit equipment performance and regulatory compliance, collaborate with cross-functional teams, assist project managers with design and cost estimates, and complete routine technical tasks under general supervision.