Jobs at FITS LLC

Leads engineering design delivery for large capital projects in pharmaceutical, biotech, warehouse, or logistics facilities. Establishes design standards and requirements, coordinates multidisciplinary design teams and A/E firms, manages design reviews and schedules, ensures regulatory and project-intent compliance, resolves design issues, tracks earned-value progress, and drives design efficiency improvements.

Develops and maintains quality standards for medical device manufacturing. Collaborates with engineering and manufacturing teams, designs inspection and testing methods, conducts quality assurance testing, performs statistical analysis, investigates nonconformances, supports validation and risk assessments, and ensures corrective actions and documentation meet reliability and compliance requirements.

Ensures suppliers deliver compliant, high-quality parts, materials, and services for medical device manufacturing. The role qualifies and monitors suppliers, resolves supplier-related quality issues, evaluates supplier performance, supports supplier changes, develops acceptance sampling strategies and control plans, coordinates approved supplier activities, and validates receiving inspection test methods. It partners with R&D, sourcing, engineering, operations, and quality teams to prevent defects and drive continuous improvement.

Leads pharmaceutical quality assurance activities, including approving process validation and environmental characterization reports, releasing sanitary utility systems, managing incidents and investigations, supporting new product introduction, and maintaining site quality procedures. Serves as QA representative on technical teams and as the QA manager’s designee for local change control review. Requires regulated-industry experience, validation expertise, bilingual English-Spanish communication, and familiarity with quality and technical systems.

Supports pharmaceutical validation and maintenance compliance across utility, process, instrumentation, electrical, cleaning, and automation systems. Evaluates systems against FDA and industry standards, supports inspections and investigations, maintains audit and training programs, coordinates technical engineering and regulatory support, and assists with engineering improvements and procedure testing.

Supports environmental, health, and safety compliance across construction and regulated-industry projects. Responsibilities include maintaining environmental procedures, identifying risks, coordinating environmental assessments, monitoring waste management systems, verifying mitigation measures, communicating requirements to contractors and communities, and supporting operational teams. The role also involves permits, reporting, job hazard analyses, rigging plans, and toolbox meetings.

Lead pharmaceutical site master planning and capital project development. Manage engineering consultants, assess infrastructure and utilities, develop cost estimates, prioritize projects, prepare Capital Authorization Requests and business cases, and present recommendations to site leadership. Coordinate Engineering, Facilities, Utilities, Operations, Manufacturing, and other stakeholders while developing long-term implementation strategies within active pharmaceutical manufacturing facilities.

Leads pharmaceutical process development studies, experiments, validation protocols, process characterization, technology transfer, and technical investigations. Analyzes and interprets data, recommends project actions, develops experimental designs, introduces advanced technologies, prepares technical documentation, and contributes to project milestones. The role also supports collaboration, mentoring, safety initiatives, recruiting, and department-wide efforts in sterile drug product manufacturing and aseptic filling operations.

Supports supplier and distribution quality for medical device manufacturing. Responsibilities include establishing approved supplier lists, negotiating quality agreements, qualifying and auditing suppliers, monitoring performance, managing supplier CAPA issues, validating receiving inspection methods, and supporting new product development. The role drives supplier quality improvement, regulatory compliance, sampling strategies, control plans, and supplier qualification while collaborating with engineering and distribution teams. Travel to contract manufacturers and suppliers is required.

Provides technical engineering expertise for HVAC, chilled water, and cooling tower systems in a regulated pharmaceutical manufacturing environment. Optimizes maintenance programs, manages quality-system activities including deviations, CAPAs, and change controls, supports electronic facilities-management forms, coordinates pest-control programs, supervises contractors, and partners with project managers and engineering firms on facility and utility projects.

Supports project managers and engineers on pharmaceutical and regulated-industry capital construction projects. Responsibilities include coordinating contractors, organizing construction documentation, reviewing drawings and invoices, tracking RFIs, change orders, permits, materials, punch lists, and closeout activities. The coordinator also participates in design reviews, pre-bid meetings, construction meetings, verification activities, and daily site documentation while supporting communications among owners, contractors, engineering, maintenance, environmental, and security teams.

Maintain integrated Commissioning and Qualification schedules, including plans, actuals, forecasts, baselines, progress updates, and scenario analysis. Coordinate schedule activities with document readiness and field execution, support impact analysis and weekly or monthly reporting, communicate schedule risks and drivers, escalate issues, and collaborate with the Project Integrator to keep C&Q activities aligned with the overall project schedule.

Develop and maintain project training plans and matrices, identify applicable SOP and compliance training, establish learning plans, coordinate training sessions, audit personnel training compliance, and manage onboarding requirements including contractor safety, site access, system access, and electronic devices. The role supports regulated engineering projects and requires fluent Spanish and English communication.

Leads automation commissioning, qualification, and computer system validation for regulated pharmaceutical or biotech capital projects. Provides technical direction on automation architecture, software development, testing, technical changes, CSV strategy, and validation documentation. Leads IQ/OQ/PQ protocols, coordinates with Quality Assurance and engineering teams, manages deviations and change controls, supports FAT/SAT, develops training materials, and contributes to project schedules, reporting, and system handover.

Maintain, edit, archive, and coordinate engineering drawings and related documentation in a regulated pharmaceutical or biotech environment. Lead drawing revisions and approval workflows, manage project reporting and coordination through site communication systems, maintain required training, and follow client procedures to ensure service quality and continuity.

Leads pharmaceutical capital projects from definition and design through implementation and plant startup. Responsibilities include coordinating multidisciplinary engineering teams and contractors, managing schedules, costs, risks, bids, documentation, procurement, field execution, equipment and utility assessments, project controls, commissioning and qualification, and executive reporting while ensuring GMP, safety, security, environmental, and quality compliance.

Leads cross-functional New Product Introduction projects in a pharmaceutical or regulated environment. Responsibilities include project planning, execution, scheduling, budgeting, risk mitigation, resource negotiation, change control, stakeholder engagement, issue resolution, and maintaining project documentation. The role ensures scope, quality, cost, timeline, scientific, and client satisfaction objectives are achieved while coordinating with management and functional teams.

Supports analytical method transfers between laboratories by developing plans and protocols, coordinating samples, equipment, standards, training, and documentation, executing transfer testing, evaluating results against acceptance criteria, and authoring technical reports. The role also supports method validation, troubleshooting, investigations, CAPAs, change controls, deviations, audit readiness, and compliant laboratory recordkeeping in FDA-regulated pharmaceutical, biotechnology, medical device, or combination-product environments.

Leads pharmaceutical commissioning, qualification, and validation activities across engineering projects. Responsibilities include CQ planning, milestone tracking, multidisciplinary coordination, execution readiness, P&ID walkdowns, punch-list and deviation management, change control, vendor coordination, test-plan review, training documentation, CQV filing, and schedule/resource compliance. Requires pharmaceutical validation lifecycle exposure, process commissioning and qualification experience, cGMP and data integrity knowledge, bilingual Spanish and English communication, and strong English documentation skills.

Leads pharmaceutical manufacturing quality investigations, CAPA and change control activities, trend evaluations, process monitoring, validation protocols, regulatory submissions, and manufacturing documentation. Supports new product introductions, process and equipment improvements, troubleshooting, regulatory inspections, permits, safety evaluations, and compliance initiatives. Partners with managers and supervisors to improve productivity, yields, cycle times, equipment performance, and product quality while ensuring manufacturing processes meet regulatory and quality requirements.