Title:  Principal Specialist, QA Validation

Job Title:      Principal Specialist, QA Validation

Location:      Columbus, OH

Job Type:     Full time

Req ID:         11652

About Us:  

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

Description:

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 Principal Specialist, QA Validation to join our team.  

In this role, you will be responsible for approval of testing strategies and validation deliverables for cleaning, computer, equipment, process, analytical, and material evaluations to ensure requirements/results are compliant to the applicable business and regulatory standards. Executes initial and final quality review of associated change controls as well as final approval of periodic reviews. 

Key Responsibilities: 

1. 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.

These tasks are performed:

• To proactively ensure compliance with regulatory, corporate, and industry guidelines.
• Ensure that the principles of validation and qualification are captured and maintained throughout the lifecycle
• To ensure the needs of the business are being met in an appropriate time frame

These tasks are accomplished by:

• Review and approval of technical documents/reports
• Ensures that all critical compliance factors have been taken into consideration and are appropriately/fully addressed
• Using Technical skills and attention to detail to ensure quality and timeliness of documents
• Supports audits of Regulatory Authorities and Corporate auditors

2. Executes approvals within the change control process of the following quality systems:  cleaning validation, computer validation, equipment validation, process validation, analytical validation, and material evaluations.

These tasks are performed:

• To ensure compliance with regulatory and corporate guidelines which keep systems in a validated state
• To ensure the needs of the business are being met in an appropriate time frame

These tasks are accomplished by:

• Using technical skills to evaluate impact to the validated state of cleaning, computers, equipment and materials
• Ensures that all critical compliance factors have been taken into consideration and are appropriately/fully addressed within the change control and identified deliverables.
• Support audits of Regulatory Authorities and Corporate Auditors

3. Approves periodic reviews which evaluate the validated state of cleaning processes, computerized system and equipment.

These tasks are performed:

• To ensure policies, procedures and practices keep systems/processes in good standing and in a validated state
• To ensure the effectiveness of the associated quality system

These tasks are accomplished by:

• Keeping abreast of industry trends and expectations from corporate requirements and regulatory agencies
• Approval of periodic review documents as required
• Ensure appropriate follow up mechanisms are in place

4. Contributes to the development, management and improvements of validation quality systems including associated policies, procedures, guidelines, and templates in the area of validation.

These tasks are performed:

• To proactively ensure compliance with regulatory, corporate and industry guidelines and standards
• To create clear guidance and expectations for the company concerning validation
• To ensure a consistent approach  to change management, validation and qualification

• To ensure consistency of approach and understanding of polices, procedures and regulations
• To continue the growth of technical knowledge within functional areas

These tasks are accomplished by:

• Developing and presenting training material and literature

Other duties as assigned.

Predicable onsite attendance required.

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them: 

• 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.

Preferred Qualifications:

• Advanced degree in engineering or related scientific discipline.
• QA pharmaceutical experience.
• Knowledge of application software such as Trackwise, SAP, IDEA or RECORD preferred.

What We Offer*:

• 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

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

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