Fill Operator I

Hikma Pharmaceuticals; Bedford (OH); On-site; USD 42,000 - 52,000; Full time

Benefits offered by this job

Annual bonus

401(k) match

PTO 20 days

Personal days

Benefits package

Employee discount

Career growth

Parental leave

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Filling Operator I to join our manufacturing team in Ohio. The role covers full spectrum duties in Parts Preparation, Compounding/Formulation, and Filling with emphasis on aseptic technique and clean room practices.

No supervisory responsibilities; focus on quality and compliance with cGMPs and SOPs. The successful candidate will have a high school diploma, at least one year of production equipment experience, and be able to document processes

Qualifications

• Minimum high school diploma or equivalent.
• Minimum 1 year experience operating production equipment.
• Aseptic technique training and clean room experience preferred.

Responsibilities

• Attend onsite regularly and on time.
• Operate parts preparation, compounding and filling equipment per procedures.
• Set up and operate compounding/formulation tanks and automated filling equipment.
• Perform quality checks and logbook entries as required.
• Report maintenance and safety issues to supervisor.
• Work overtime as production demands.

Skills

Communication

Documentation

Education

High school diploma or equivalent

Job description

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 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 global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

JOB PURPOSE

The Filling Operator I will be responsible for the full spectrum of duties in controlled Parts Preparation, Compounding/Formulation, and Filling. This job has no supervisory responsibilities.

KEY ACCOUNTABILITIES

• Regular and predictable onsite attendance and punctuality.
• Ability to perform all job duties using acceptable aseptic technique.
• Ability to perform job duties in one or two of the following areas of manufacturing to include:
• Parts and production preparation to include use of Parts Washer and Autoclave.
• Dispensing of excipients and API in preparation for compounding.
• Sets up and operates Compounding/Formulation tanks and equipment.
• Sets up & operates automated filling and support equipment such as filler/isolator, filter and glove testing.
• Completes applicable paperwork and logbook entries for compounding and filling rooms in accordance with approved procedures.
• Follows all written procedures for operation of the compounding and fill rooms.
• Performs clean-up of equipment and room, including walls and floor, as necessary.
• Collects samples, performs fill weight checks and other quality checks as necessary.
• Assists with or performs preventive maintenance tasks on compounding and filling equipment, such as inspection and cleaning of machine parts, as may be required.
• Refers process issues to Supervisor or designee
• Informs supervisor of maintenance and/or safety issues.
• Works overtime with short notice when production requires.
• Performs all other duties as determined by management personnel.

QUALIFICATIONS

• Minimum: High school diploma or equivalent.

EXPERIENCE

• Minimum: Minimum of 1 (one) year experience operating production equipment.
• Preferred: Prior aseptic technique training and working in a clean room environment.

SKILLS

Language Skills:

• Good oral and written communication skills are essential. Must be able to document process issues in a clean, concise manner in accordance with cGMPs and SOPs
• Ability to read and interpret written documents such as safety rules, operating and maintenance instructions and procedure manuals.
• Ability to complete required documentation such as production batch records.

Mathematical Skills:

• Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and/or decimals.

Reasoning Ability:

• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

Physical Demands:

• While performing the duties of this job, the employee is required to stand for long periods of time and must be able to lift 30 lbs. This job requires frequent bending, twisting, pushing, pulling, and lifting. Use of Sanitizing agents to maintain cleanroom environment.
• Filling Operator I must work in areas totally gowned with mask, hood, coverall and gloves. The conditions are difficult to work in. At times the environment can be confining. The noise level is moderate to loud. Use of hearing protection may be required. The use of sanitizing agents to clean area may be moderately disagreeable.

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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)
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• 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.

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.