Pharmaceutical Specialist II

7 days ago

Columbus, Ohio, United States Hikma Pharmaceuticals PLC Full time

Job Title:
Specialist II, Cleaning Validation

Job Type:
Full time

Hikma Pharmaceuticals USA Inc. and its affiliates' mission is to bring Better Health.

We are a trusted, reliable partner and dependable source of over 750 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 8,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

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 Specialist II, Cleaning Validation to join our team.

In this role, you will be responsible for supporting site cleaning and cleaning validation processes from product development through product lifecycle.

You will revise and train on cleaning procedures and educate those performing the cleaning on the expectations and intent of cleaning, inspection, and cleaning verification sampling.

Maintains the cleaning validation requirements ensuring compliance to the applicable business and regulatory standards.

Documents the performance and compliance of the cleaning validation program.

Develop procedures for cleaning processes utilized in operations including cleaning, inspection, and cleaning verification work instructions.

Optimize and improve the consistency and effectiveness of cleaning processes developing a validation deliverable, which comply with regulatory guidelines and business requirements.

Support employee training to ensure compliance to procedure and process effectiveness.

Conduct periodic reviews of the compliance of cleaning processes and to ensure the effectiveness of the cleaning validation program.

Coordinate data collection, organization, and archival for cleaning validation program including testing for new and existing products, changes to cleaning processes or equipment, and new equipment.

Maintains the Master Data and execute product, equipment, and system evaluations using a risk-based approach including performing required calculations.

Design and author technical protocols and reports in alignment with the philosophy defined by the Cleaning Validation engineering team.

Compile cleaning verification and validation data, investigations, and change control information for technical reports related to the cleaning program.

Track equipment and product qualification status.

Participates in the development of appropriate testing strategies including swabbing location.

Support the optimization of processes including manual and automated cleaning processes.

Support the development of cleaning activities to ensure that the system's validation state is maintained.

Identify testing approach and cleaning swab sample locations on new equipment and/or for new products in alignment with the philosophy defined by the Cleaning Validation engineering team.

Participates in the creation of policies, procedures, guidelines, and templates in the area of validation.

Requirements:

Bachelor's degree in engineering or related scientific discipline required with a minimum of four (4) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting.

Require 1-3 years specific cleaning validation experience in a pharmaceutical environment.

Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable.

In lieu of a degree, require a minimum of eight (8) years of Pharmaceutical industry experience in quality, production, engineering or a laboratory setting.

Require 3 years specific cleaning validation experience in a pharmaceutical environment.

Experience by a combination of equipment qualification, process validation, or cleaning validation is acceptable.

Preferred Qualifications:

Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols, procedures and/or technical reports.

Experience and Inspection interaction with FDA, EMA or other regulatory agencies preferred.

QA pharmaceutical experience preferred.

Demonstrated proficiency in computer skills as a business tool, specific work experience using Microsoft applications (Word, Excel, PowerPoint).

Knowledge of application software such as Trackwise, SAP, IDEA or RECORD, Information mapping preferred.

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.

Additional days granted upon reaching work milestone anniversaries

~11 company paid holidays

~ Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits

~ Safety and Quality is a top organizational priority

~ Career advancement and growth opportunities

~ Tuition reimbursement

~ 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.

Hikma Pharmaceuticals PLC

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