Sterility Assurance Specialist

Job Description

Job Title: Specialist, Sterility Assurance

Location: Bedford, OH

Job Type: Full-Time

Req ID: 12641

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:

The Specialist, Sterility Assurance supports the site Sterility Assurance Program by providing technical expertise in contamination control, environmental monitoring, aseptic processing, and microbiological quality systems. This individual works closely with Manufacturing, Quality Assurance, Microbiology, Engineering, Validation, and Maintenance to support routine monitoring, investigations, compliance activities, and continuous improvement initiatives related to sterile manufacturing operations.

The Specialist is responsible for supporting the maintenance of site sterility assurance programs, assisting with investigations, reviewing data and trends, and ensuring activities comply with current GMP and regulatory requirements.

The individual shall be responsible for coordinating the timely completion of Environmental Monitoring Trend Reports and lead the remediation of environmental issues. Responsible for making Quality decisions related to Sterility Assurance for manufacturing, facility design, certification & maintenance, investigations, documentation, CAPA, change control, and regulatory compliance.

Key Responsibilities:

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• Support the site's Contamination Control Strategy (CCS) through routine monitoring, data review, and continuous improvement activities.
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• Provide sterility assurance support for:
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• Media Fill (Aseptic Process Simulation) Program
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• Environmental Monitoring (EM) Program
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• Aseptic Behavior and Gowning Programs
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• Sterilization and Sanitization Processes
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• Personnel, material, and product flow assessments within classified areas
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• Participate in investigations related to environmental monitoring excursions, contamination events, media fill failures, and other sterility assurance concerns.
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• Review and assess deviations, CAPAs, and change controls for potential sterility assurance impact.
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• Assist in the evaluation of classified manufacturing areas to ensure compliance with facility fit-and-finish requirements.
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• Support generation and review of environmental monitoring trend reports and annual assessments.
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• Review environmental monitoring data and escalate adverse trends as appropriate.
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• Collaborate with Manufacturing, Quality Assurance, and Microbiology teams to support aseptic processing operations.
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• Assist with training activities related to aseptic techniques, gowning practices, cleanroom behaviors, and contamination prevention.
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• Support maintenance of sterility assurance procedures, policies, and documentation to ensure compliance with regulatory expectations and industry best practices.
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• Participate in internal audits, regulatory inspections, and client audits as a sterility assurance technical resource.
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• Support microbiological method qualification and monitoring activities, as applicable.
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• Assist in ensuring media fill programs adequately represent manufacturing operations, interventions, and aseptic process requirements.
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• Support environmental monitoring activities to ensure personnel, facilities, and processes remain in a state of control.
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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

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

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

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

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• Annual performance bonus, commission, and share potential
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• 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
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• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
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• 3 personal days (prorated based on hire date)
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• 11 company paid holidays
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• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
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• Employee discount program
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• Wellbeing rewards program
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• Safety and Quality is a top organizational priority
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• Career advancement and growth opportunities
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• Tuition reimbursement
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• Paid maternity and parental leave
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*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.