Lead Planner – CQV
2 days ago
Allentown
Lead Planner – CQV Company: EFOR Group Location: Allentown, Pennsylvania Employment Type: Full-time position with EFOR Group Work Arrangement: Remote for the first three months, followed by full-time onsite work Project Environment: New-build parenteral manufacturing facility Base Salary: $145,000–$165,000 annually, depending on experience About EFOR Group EFOR Group is a global Life Sciences consulting organization supporting pharmaceutical, biotechnology, and medical-device companies across engineering, project management, project controls, commissioning, qualification and validation, quality, automation, digital transformation, and regulatory compliance. EFOR is seeking an experienced Lead Planner – CQV to support commissioning, qualification, validation, startup, and operational-readiness activities for a major new-build parenteral manufacturing facility in Allentown, Pennsylvania. Position Overview The Lead Planner – CQV will develop, integrate, maintain, and analyze detailed schedules across the commissioning, qualification, and validation workstreams. The successful candidate will work closely with construction, engineering, automation, quality, validation, system owners, equipment vendors, operational-readiness teams, and project leadership to ensure that system completion, turnover, commissioning, qualification, and startup activities are properly sequenced and aligned with the integrated master schedule. This role requires a planning professional who understands both project-controls principles and the technical dependencies associated with pharmaceutical CQV execution. Work Arrangement The position will initially be performed remotely for approximately three months. During this period, the planner will support onboarding, schedule development, systemization planning, stakeholder coordination, and initial CQV planning activities. Following the initial three-month period, the position will transition to full-time onsite work at the project location in Allentown, Pennsylvania. Candidates must be willing and able to relocate to or regularly commute within the Allentown area. Periodic site visits may be required during the initial remote phase based on project needs. Key Responsibilities • Develop and maintain detailed commissioning, qualification, and validation schedules using Oracle Primavera P6., • Integrate CQV activities into the overall project integrated master schedule., • Develop schedule logic covering construction completion, mechanical completion, system turnover, commissioning, IQ, OQ, PQ, validation, startup, and final handover., • Coordinate planning activities with construction, engineering, automation, quality, validation, equipment vendors, system owners, and operations teams., • Support systemization planning by aligning systems, subsystems, areas, turnover packages, and supporting documentation., • Track equipment, utilities, automation, documentation, and system readiness for commissioning and qualification., • Integrate vendor activities, including design reviews, FAT, SAT, installation, commissioning support, testing, documentation delivery, and final acceptance., • Coordinate the sequencing of commissioning protocols, qualification protocols, test execution, deviations, punch-list closure, and system release., • Monitor progress against approved baselines and identify risks affecting CQV, startup, and operational-readiness milestones., • Perform critical-path, near-critical-path, float, interface, and schedule-health analyses., • Develop detailed rolling look-ahead schedules for CQV and turnover execution teams., • Facilitate schedule-review meetings with CQV leads, system owners, contractors, vendors, and project stakeholders., • Validate progress updates and confirm that reported completion is supported by appropriate evidence., • Identify schedule conflicts involving construction completion, utilities availability, automation readiness, documentation, resource availability, and qualification execution., • Develop mitigation plans and recovery schedules for delayed turnover, commissioning, or qualification activities., • Prepare weekly and monthly CQV schedule reports, milestone summaries, dashboards, S-curves, look-ahead schedules, and variance narratives., • Assess schedule impacts resulting from deviations, change controls, technical issues, late documentation, equipment delays, or resource constraints., • Support resource-loading and workload forecasting for commissioning and qualification teams., • Maintain accurate schedule assumptions, constraints, risks, dependencies, and change records., • Coordinate CQV schedule interfaces with engineering, construction, automation, quality, manufacturing, and operational-readiness workstreams., • Support compliance with project procedures, GMP expectations, and applicable validation requirements. Required Qualifications • Bachelor’s degree in engineering, life sciences, construction management, project management, or a related discipline., • At least 8 years of experience in project planning, scheduling, project controls, commissioning, or qualification., • At least 5 years of experience supporting CQV activities within pharmaceutical, biotechnology, or regulated manufacturing environments., • Strong proficiency with Oracle Primavera P6., • Demonstrated experience developing detailed CQV, turnover, commissioning, validation, startup, or operational-readiness schedules., • Strong understanding of pharmaceutical project delivery from construction completion through system handover and operational readiness., • Knowledge of mechanical completion, system turnover, commissioning, IQ, OQ, PQ, validation, startup, and final acceptance processes., • Ability to manage schedule interfaces among construction, engineering, automation, quality, validation, equipment vendors, and operations., • Experience performing critical-path analysis and developing recovery schedules., • Strong analytical, reporting, coordination, and stakeholder-management skills., • Excellent written and verbal communication skills., • Ability to work independently while supporting multidisciplinary project teams., • Ability and willingness to transition to full-time onsite work in Allentown following the initial remote period. Preferred Qualifications • Experience supporting a new-build parenteral, aseptic, biologics, or sterile-manufacturing facility., • Experience with systemization, turnover packages, commissioning-management systems, or validation-management platforms., • Familiarity with Kneat, Veeva, TrackWise, or comparable quality and validation systems., • Experience with process equipment, clean utilities, HVAC, laboratories, automation, packaging, or manufacturing systems., • Knowledge of GMP, GDP, data integrity, and validation lifecycle requirements., • Experience integrating schedules from multiple contractors, equipment vendors, and CQV execution teams., • Experience supporting large greenfield pharmaceutical capital programs., • Familiarity with Power BI, advanced Excel reporting, earned-value management, or schedule-health analysis tools. Compensation and Benefits The anticipated base salary range is $145,000–$165,000 annually. Final compensation will be determined based on experience, CQV knowledge, Primavera P6 capability, and overall alignment with the position. EFOR provides a competitive benefits package, subject to plan eligibility and applicable employment terms, which may include: • Medical, dental, and vision insurance, • 401(k) retirement plan, • Paid time off and company holidays, • Life and disability insurance, • Professional-development and technical-training opportunities, • Access to EFOR’s international network of Life Sciences experts, • Career-development opportunities across project controls, CQV, engineering, and program leadership, • Opportunities to support major pharmaceutical capital programs across the United States