Aseptic Services Operator I (2nd Shift)

Use Your Power for Purpose

Our breakthroughs rely on the expertise of our dedicated pharmaceutical manufacturing team to reach those in need. Your role here will be critical as you leverage your skills and knowledge to ensure that essential medicines are produced efficiently and delivered promptly. By embracing agility and commitment your contributions will significantly improve patient outcomes and reinforce the profound impact of our collective efforts. Together we ensure that both patients and physicians have timely access to necessary medicines.

What You Will Achieve

Aseptic Services Operators are responsible for ensuring the aseptic processing facility (APA) is cleaned and sanitized according to rigorous regulatory standards in order to maintain a world class sterile processing facility for injectable products. Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e. GMPs & OSHA). This job includes the following functions:

• Performing routine cleaning and sanitization tasks within the facility
• Operation of cleaning equipment and machinery
• Achieving and maintaining aseptic certification to work within graded spaces
• Documenting GMP tasks according to standard operating procedures
• Responding to special clean requests as needed
• Managing and maintaining gowning rooms and staging areas
• Working safely and compliantly following all applicable SOPs and standards including recording of GMP documentation
• Completing and maintaining all required training on time
• Achieving and maintaining power industrial equipment certification
• Working with potentially hazardous cleaning and sanitization agents
• Demonstrating growth mindset to share best practices utilize downtime effectively and learning aseptic technique
• Demonstrating ownership and accountability of the production schedule and product quality
• Other duties as assigned by the supervisor

Here is What You Need (Minimum Requirements)

• HS Diploma with any years of experience
• Knowledge of cGMP and regulatory compliance
• Proficiency in using manufacturing equipment and tools
• Competence in troubleshooting and performing quality checks
• Demonstrated ability to follow established procedures and guidelines
• Experience with preparing and cleaning various components materials and equipment
• Strong organizational and documentation skills

Bonus Points If You Have (Preferred Requirements)

• Experience in pharmaceutical production

• Practical knowledge in a regulated industry

• Capability to work collaboratively within a team

• Ability to develop innovative ideas to simplify processes

• Commitment to professional development

• Strong communication skills

PHYSICAL/MENTAL REQUIREMENTS

Physical Demands:

• Lifting/lowering up to 55 pounds working in high elevations (above 6 feet) and reaching/standing/walking/stooping/crawling.

• Able to wear safety PPE (Hard hat body harness face shield)

• Able to work under full clean room (GRADE A/B/C/D) environments with appropriate gowning

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Standard working hours for this position are 1400-2230. Schedule rotation is 10 days on 4 days off. Weekend holiday and overtime may be required to meet business or customer needs.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.

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