Manager, Product Validation & Product Transfer

Hikma Pharmaceuticals USA Inc.•Cherry Hill, NJ

About The Position

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated [Job Title] to join our team. In this role, you will be responsible for e nd-to-end planning, coordination, and execution management of a portfolio of site projects across process/product validation, product transfer (technology transfer), and validation/qualification workstreams. The role partners with cross-functional stakeholders to ensure projects are delivered on time, within scope, and within budget, while maintaining a high standard of GMP documentation and inspection readines s. This position supports lifecycle validation expectations (including process design, process qualification, and continued process verification) and execution of risk-based technology transfers consistent with recognized industry and regulatory expectations.

Requirements

Bachelor’s degree (B.S.) in Engineering or a scientific discipline required.
2–4 years of experience in pharmaceutical manufacturing AND 2–4 years of project management experience (may overlap depending on role history).
Knowledge of cGMPs, FDA expectations, and pharmaceutical industry practices, particularly related to validation and technical change execution.
Demonstrated working knowledge of pharmaceutical facilities and production equipment concepts (as applicable to project scope).
Proven ability to manage multiple projects simultaneously and drive closure in a matrixed environment.
Excellent client-facing and internal communication skills (written and verbal).
Strong organizational skills, attention to detail, and ability to multitask in a fast-paced environment.
Strong working knowledge of Microsoft Office (Excel, PowerPoint, Word).
Experience with project management software/tools (e.g., MS Project, Smartsheet, Jira, or equivalent).

Nice To Haves

PMP or other recognized project management certification.
Experience supporting sterile/injectable manufacturing environments.
Experience supporting technology transfer / product transfer execution and startup readiness using risk-based approaches.
Familiarity with lifecycle process validation concepts and continued process verification / ongoing monitoring.
Familiarity with EU GMP validation principles (e.g., Annex 15 concepts) as applicable to global product supply.

Responsibilities

Portfolio & Program Execution Coordinate internal resources and cross-functional teams for the flawless execution of multiple concurrent projects (validation, product transfer, room transfers, technical services deliverables).
Ensure all assigned projects are delivered on time, within scope, and within budget; maintain project baselines and controlled change management.
Lead routine project governance: cadence meetings, action logs, decision tracking, and escalation pathways.
Report project status, risks, dependencies, and recovery plans to management; escalate issues early to protect timelines and compliance commitments.
Scope, Schedule, Cost, and Change Control Meet with site leadership and project sponsors to clarify project objectives, scope, and success criteria; keep projects aligned to site goals and business priorities.
Assist in defining scope and objectives, involving all relevant internal stakeholders and ensuring technical feasibility.
Build and maintain long- and short-term plans, including milestone targets, critical path, and resource forecasts.
Manage changes to project scope, schedule, and cost using appropriate verification techniques; ensure impacts are understood and approved through the correct governance route.
Risk & Decision Management Perform risk management to minimize potential risks, including creation/maintenance of risk registers and mitigation plans.
Make effective, timely decisions when presented with multiple options for progressing work; document decision rationale and resulting actions.
Drive closure by aligning owners and due dates, tracking completion, and removing barriers.
Stakeholder & Resource Management Manage relationships with site leadership and relevant stakeholders; maintain alignment across functions and shifts.
Facilitate resource availability and allocation across competing priorities; proactively identify constraints and recommend options/tradeoffs.
Delegate project tasks based on team members’ strengths, skill sets, and experience levels; ensure accountability for deliverables.
Quality & Documentation Control Perform quality control throughout project execution to maintain expected standards (GMP documentation quality, completeness, traceability).
Create and maintain comprehensive project documentation (project charters, plans, schedules, risk registers, meeting minutes, action logs, timelines).
Develop comprehensive project plans to share with team members and stakeholders; maintain visibility dashboards and reporting.
Track and analyze project performance using appropriate project management tools and techniques; measure performance against short- and long-term goals.
Cross-Functional Interfaces (Core Collaboration) Site Engineering: Partner to define project scope, equipment/process design inputs, schedule generation/execution, and recurring status reviews.
Technical Services / Validation SMEs: Align validation and transfer needs, deliverables, and timing; maintain disciplined readiness and document flow.
Manufacturing: Align to production needs, coordinate labor/resources, and communicate schedules and execution windows.
QA/QC & EHS: Coordinate documentation approvals, compliance requirements, and impact assessments; communicate schedules and status.
Vendors/Contractors: Coordinate project-related follow-up, deliverables, and timeline commitments; track contractor actions and integration into overall plan.

Benefits

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Safety and Quality is a top organizational priority
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave