Communications & Working Relationships

Internal: Manufacturing, Quality Assurance, Microbiology, Engineering, Validation, Maintenance
External: Works with regulatory inspectors, contract laboratories, equipment and service vendors, consultants, and external partners to support environmental monitoring, contamination control, sterility assurance programs, and regulatory compliance activities.

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:

Education

• Bachelor’s Degree in Microbiology, or relevant degree and/or experience.

Experience

• Minimum: 3-5 years of experience in sterile pharmaceutical manufacturing, microbiology, quality assurance, sterility assurance, or related functions within an FDA-regulated environment
• Experience supporting environmental monitoring programs and aseptic manufacturing operations.
• Working knowledge of contamination control principles and cleanroom operations.
• Familiarity with aseptic process simulations (media fills) and sterile manufacturing practices.
• Experience supporting FDA, client, or regulatory inspections.
• Ability to participate in investigations, deviation management, CAPA activities, and root cause analysis.
• Knowledge of microbiological testing methods and cleanroom qualifications.
• Understanding of cGMP requirements and applicable regulatory expectations.
• Experience in sterile injectable manufacturing is strongly preferred.

Skills

• Strong technical writing, communication, and organizational skills.
• Partner with Quality Assurance and Manufacturing to ensure compliance with applicable GMP regulations and company procedures.
• Support continuous improvement initiatives related to contamination control, environmental monitoring, and aseptic processing.
• Develop working knowledge of applicable regulations and guidance, including 21 CFR Parts 210 and 211, EU Annex 1, and current GMP requirements.
• Maintain inspection readiness through accurate documentation, data review, and timely completion of assigned activities.

Compensation

Base Salary: $44,900 to $74,950 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

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.