Aseptic Technician

Aseptic Technician

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.

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 Aseptic Technician to join our team. In this role, you will be responsible for performing routine viable and non-viable environmental monitoring activities within ISO 5 and ISO 7 classified areas. This includes collecting and documenting environmental monitoring samples in accordance with approved procedures, protocols, and cGMP requirements; operating and maintaining applicable monitoring equipment; and identifying and escalating any excursions or abnormal conditions. The Aseptic Technician also supports environmental monitoring program compliance by maintaining proper aseptic technique, adhering to gowning and personnel practices, ensuring sampling activities do not compromise product or process integrity, and maintaining a clean, controlled, and compliant manufacturing environment.

Key Responsibilities:

• Performs routine viable and non-viable environmental monitoring activities within ISO 5 and ISO 7 classified rooms, as well as designated non-controlled areas, in accordance with approved procedures, sampling plans, cGMP requirements, and site environmental monitoring practices.
• Ensures environmental monitoring samples are collected accurately, consistently, and within established timeframes while maintaining proper aseptic technique and preventing contamination of classified areas or monitoring samples.
• Maintains adequate inventory of environmental monitoring and testing supplies within aseptic areas, ensuring materials are properly stored, readily available, and within applicable expiration or usage requirements.
• Coordinates and communicates effectively with peers, management, Quality, and other applicable departments to ensure all scheduled environmental monitoring activities are completed accurately, on time, and in accordance with established requirements.
• Completes all required environmental monitoring documentation accurately, legibly, and contemporaneously, ensuring records are complete, traceable, and compliant with applicable data integrity and documentation requirements.
• Reviews monitoring activities and documentation for completeness and promptly communicates any discrepancies, abnormal observations, potential excursions, or other concerns to appropriate personnel for evaluation and follow-up.
• Maintains a strong working knowledge of aseptic practices, classified-area requirements, contamination control principles, gowning procedures, and applicable SOPs and cGMP expectations.
• Maintains a clean, organized, and inspection-ready work environment and ensures monitoring equipment, supplies, and materials are handled and maintained in accordance with established procedures.
• Performs other duties and responsibilities as assigned by management in support of departmental objectives, manufacturing operations, quality requirements, and overall site compliance.

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
  Minimum: Highschool Degree
• Skills
  Must practice current Good Manufacturing Practices (cGMP).
  Must have knowledge of the gowning process required for ISO 5/7 classified rooms and the ability to gown utilizing aseptic technique.
  Must be able to pass and maintain gowning qualification.
  Must be able to pass and maintain media fill qualification.
  Must be self-motivated, detail oriented and have strong organizational skills.
  Must have excellent verbal and written communication skills to effectively communicate with all levels of personnel.
  Must be computer literate.
  Must be able to multi-task and manage time effectively.

Physical Demands:

• The gowning function of the position requires frequent bending, twisting and reaching.

Work Environment:

• Aseptic Tech must work in aseptic clean room areas totally gowned with mask, goggles, hood, coverall, boots and gloves.

Compensation:

Hourly Rate: $24 per hour; $26 per hour after being gown qualified. 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.

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.

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.