Pharmaceutical Specialist II

3 weeks ago

Columbus, Ohio, United States Hikma Pharmaceuticals PLC Full time
Job Title: Specialist II, Cleaning Validation

Job Type: Full time

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 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.

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 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. You will maintain the cleaning validation requirements ensuring compliance to the applicable business and regulatory standards. You will document the performance and compliance of the cleaning validation program.

Key Responsibilities:
  • 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 complies 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. Coordinate sampling logistics (batch identification and tracking). Maintain 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. Participate 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. Participate in the creation of policies, procedures, guidelines, and templates in the area of validation.
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 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.
  • Experience with the authoring and execution of Quality documentation including validation documentation, technical protocols, procedures and/or technical reports.
Preferred Experience: The items below are preferred but not required:
  • 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.
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 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
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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