Principal Specialist, QA Validation

Hikma Pharmaceuticals

Principal Specialist, QA Validation managing validation strategies and deliverables in pharmaceutical settings. Collaborating across teams to ensure compliance and quality processes.

Posted 6/9/2026full-timeColumbus • Ohio • 🇺🇸 United StatesLeadWebsite

About the role

Key responsibilities & impact

Approves validation deliverables which are in compliance with regulatory guidelines and business requirements.
Ensures appropriate validation and testing strategies for cleaning validation, computer validation, equipment validation, process validation, analytical validation, and material evaluations are developed and followed.
Review and approval of technical documents/reports
Supports audits of Regulatory Authorities and Corporate auditors
Executes approvals within the change control process of quality systems: cleaning validation, computer validation, equipment validation, process validation, analytical validation, and material evaluations.
Approves periodic reviews which evaluate the validated state of cleaning processes, computerized system and equipment.
Contributes to the development, management and improvements of validation quality systems including associated policies, procedures, guidelines, and templates in the area of validation.

Requirements

What you’ll need

Bachelor’s degree in engineering or related scientific discipline.
8 years of pharmaceutical industry experience in quality, production, engineering or a laboratory setting.
3+ years of specific validation experience in a pharmaceutical environment by a combination of equipment qualification, process validation, computer validation, analytical validation or cleaning validation is acceptable.
Strong organizational skills with ability to manage multiple projects and deadlines.
Self-motivated and able to work independently.
Proven ability to multitask in high-volume environments.
Ability to quickly shift priorities and adapt between projects.
Strong problem-solving and critical thinking skills.
Experience authoring and executing quality and validation documentation (protocols, reports, technical documents).
Solid knowledge of FDA cGMP requirements.
Effective written and verbal communication skills, including technical writing.
Strong collaboration, influencing, and negotiation skills; ability to manage competing priorities and facilitate meetings across all organizational levels.
Proficient in Microsoft Office (Word, Excel, PowerPoint).
Ability to assess compliance with regulatory and corporate standards and implement effective solutions.
Capable of independent decision-making, including approval of validation documents and interaction with regulatory agencies (e.g., FDA, EMA).
Strong analytical skills to evaluate processes, ensure validation completeness, and support efficient, compliant operations.

Benefits

Comp & perks

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% 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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

validationcleaning validationcomputer validationequipment validationprocess validationanalytical validationequipment qualificationquality documentationtechnical writingFDA cGMP compliance

Soft Skills

organizational skillsself-motivatedmultitaskingproblem-solvingcritical thinkingeffective communicationcollaborationinfluencingnegotiationindependent decision-making