Validation Project and Engagement Manager

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

Plan, lead, and control the delivery of JCA validation, qualification, and procedural documentation services for the expansion of a validated LabWare Laboratory Information Management System (LIMS) supporting GMP Quality Control laboratory operations. Serve as the single point of accountability to the client for scope, schedule, cost, resources, and deliverable quality, ensuring that the JCA team delivers inspection-ready results in accordance with the contract, client quality requirements, and the JCA Quality Management System, from project initiation through closure.

RESPONSIBILITIES

• -Serve as JCA’s single point of contact and accountable engagement lead with the client Project Manager and System Owner for all contractual, schedule, resource, and performance matters.
• -Develop and maintain the JCA engagement plan, work breakdown structure, and resource plan aligned with the client project lifecycle (Plan, Design, Build, Test, Deploy) and the preliminary project schedule.
• -Provide input on activity sequencing, dependencies, durations, and resource requirements to support refinement and baselining of the client’s integrated project schedule, including validation milestones.
• -Allocate and level JCA resources across project phases, scaling qualification capacity for protocol dry runs and formal execution, and coordinating onsite presence and travel logistics for the client facility in Rancho Cordova, California.
• -Track progress, deliverable status, and hours against estimates by work package (project meetings and coordination, lifecycle documentation, qualification, procedure development, project management, and travel), and report status, risks, and issues to client and JCA management.
• -Maintain risk, issue, action, and decision logs; proactively escalate risks affecting schedule or quality, including configuration baseline readiness, client review turnaround, and resource availability.
• -Manage scope and change control for the engagement, evaluating out-of-scope requests and preparing change requests and estimates for client approval.
• -Administer the Time and Materials allowance for improvements to existing LIMS functionality, including the work authorization process, tracking of hours consumed, and ensuring that only authorized and performed work is invoiced.
• -Monitor document review and revision cycles against the number of cycles included in the proposal, and manage the associated assumptions with the client.
• -Execute the backup resource strategy, including cross-training, onboarding of backup resources, and coordination of any key-resource substitution with prior client approval, ensuring resource continuity through project completion.
• -Ensure deliverables undergo JCA internal quality review prior to client submission and comply with client document-control, validation, and quality requirements.
• -Coordinate resource onboarding, including client site access, required client training, system access requests, and confidentiality agreements.
• -Prepare cost reports, forecasts, and invoicing support, and support contract administration activities.
• -Facilitate the project kickoff, recurring status meetings, lessons-learned sessions, and engagement closure, including confirmation of deliverable acceptance and completion of knowledge transfer.
• -Comply with client and JCA Quality Management System (ISO 9001) requirements, including training, document control, and confidentiality obligations.

REQUIREMENTS & QUALIFICATIONS

Education

• -Bachelor’s degree in Engineering, Life Sciences, Computer Science, Information Systems, Business Administration, or a related field.
• -An equivalent combination of education and directly related GMP experience may be considered.

Required

• -Solid knowledge of project management principles (scope, schedule, cost, risk, resource, communication, and change management) applied to regulated validation projects.
• -Working knowledge of the computerized-system validation lifecycle, GAMP 5, 21 CFR Part 11, and data integrity requirements, sufficient to plan, estimate, and challenge validation effort and deliverables.
• -Ability to manage Time and Materials and Fixed Price budgets, including forecasting, variance analysis, and change requests.
• -Proficiency with scheduling and project tools (e.g., Microsoft Project, Smartsheet) and Microsoft Office applications (Word, Excel, PowerPoint).
• -Strong stakeholder management, negotiation, and conflict-resolution skills, with the ability to maintain a constructive client relationship under schedule pressure.
• -Ability to lead and coordinate distributed teams working onsite and remotely.
• -Strong organizational skills, attention to detail, and ability to anticipate and resolve risks before they affect the schedule.
• -Excellent oral and written communication skills in English; Spanish is a plus.
• -Client-focused, accountable, and able to work independently with minimal supervision.
• -Minimum of seven (7) years of experience in the pharmaceutical, biotechnology, or other GMP-regulated industry.
• -Minimum of three (3) years managing validation, Computer System Validation, or computerized-system implementation projects (e.g., LIMS, MES, ERP, or laboratory systems).
• -Experience managing client-facing consulting engagements with multidisciplinary teams.
• -Experience managing project budgets, resource plans, and change requests under Time and Materials and/or Fixed Price models.
• -Experience working within phased project lifecycles, integrated project schedules, and change control processes.

Preferred

• -Project Management Professional (PMP), CAPM, or equivalent project management certification.
• -Experience managing LIMS implementation, expansion, or upgrade projects; LabWare LIMS experience is preferred.
• -Experience managing projects that include ERP integrations (e.g., Oracle, SAP).
• -Hands-on background in Computer System Validation or Quality Assurance.
• -Experience managing hybrid onsite/remote teams, including travel planning and onsite execution windows.
• -Familiarity with iterative or agile configuration approaches within a validated environment.
• -ISPE GAMP training or equivalent is a plus.