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Project Manager, Validation & Product Transfer jobs in United States
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Hikma Pharmaceuticals · 1 day ago

Project Manager, Validation & Product Transfer

Hikma Pharmaceuticals is seeking a Project Manager responsible for end-to-end planning, coordination, and execution management of site projects across process/product validation and technology transfer. The role involves partnering with cross-functional stakeholders to ensure timely and budget-compliant project delivery while maintaining high standards of GMP documentation.
Health CareMedicalPharmaceutical
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H1B Sponsor Likelynote

Responsibilities

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
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
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
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
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
Partner to define project scope, equipment/process design inputs, schedule generation/execution, and recurring status reviews
Align validation and transfer needs, deliverables, and timing; maintain disciplined readiness and document flow
Align to production needs, coordinate labor/resources, and communicate schedules and execution windows
Coordinate documentation approvals, compliance requirements, and impact assessments; communicate schedules and status
Coordinate project-related follow-up, deliverables, and timeline commitments; track contractor actions and integration into overall plan

Qualification

CGMP KnowledgePharmaceutical ManufacturingProject ManagementRisk ManagementMicrosoft OfficeProject Management SoftwareMultitaskingPMP CertificationTechnology TransferLifecycle ValidationCommunication SkillsOrganizational SkillsAttention to Detail

Required

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)

Preferred

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

Benefits

401(k) matching
Dental insurance
Health insurance
Paid time off
Vision insurance

Company

Hikma Pharmaceuticals

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Hikma focuses on a wide range of generic, branded generic and in licensed pharmaceutical products

H1B Sponsorship

Hikma Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (16)
2024 (23)
2023 (22)
2022 (24)
2021 (28)
2020 (18)

Funding

Current Stage
Public Company
Total Funding
$250M
Key Investors
International Finance Corporation
2025-07-15Post Ipo Debt· $250M
2005-11-04IPO

Leadership Team

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Said Darwazah
Chief Executive Officer
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Khalid Nabilsi
Chief Financial Officer
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Company data provided by crunchbase