Now hiring an Aseptic Process Manager – Direct Hire
Compensation: $100,000–$120,000 annually, depending on experience (DOE)
Industry: Pharmaceutical Manufacturing
Schedule: Mon-Fri 8 am to 5 pm
Position Summary
The Manager of Aseptic Operations is a critical technical leadership role responsible for the daily execution of sterile manufacturing processes. This individual oversees cleanroom operations, ensuring that all products are filled and finished under conditions that maintain absolute sterility while strictly adhering to ISO 5/Class 100 standards and global regulatory requirements.
Essential Functions
Other duties may be assigned.
- Lead daily filling, capping, and lyophilization operations within appropriately ISO-classified rooms.
- Ensure 100% compliance with aseptic processing requirements, including strict gowning protocols and environmental monitoring (EM) standards.
- Design and oversee Aseptic Process Simulations (Media Fills) to validate the sterility of the manufacturing process.
- Partner with Engineering on the IQ/OQ/PQ of aseptic filling lines, autoclaves, and depyrogenation tunnels.
- Manage the validation and execution of SIP/CIP (Sterilization/Cleaning-in-Place) protocols.
- Lead investigations into environmental monitoring excursions or mechanical failures occurring during aseptic processing.
- Develop and refine Standard Operating Procedures (SOPs) specifically addressing sterile interventions and cleanroom behavior.
- Manage the Gowning Qualification and Aseptic Qualification programs for all production staff.
- Collaborate with cross-functional teams to maintain aseptic manufacturing project goals and timelines.
- Assist in the development of Cost of Goods Sold (COGS) for aseptic processing.
- Support the completion of all required documentation, including Master Batch Records (MBRs), Electronic Batch Records (EBRs), protocols, SOPs, and related documentation.
- Mentor less experienced operators and assist in identifying their training needs.
- Comply with site-wide and departmental procedures, including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
- Perform operations in a cleanroom environment, applying appropriate controls to ensure aseptic processing, including gowning and cleaning procedures.
- Maintain regular and reliable attendance on a full-time basis.
- Exhibit professional behavior with internal and external business associates that reflects positively on the company and is consistent with company policies and practices.
- Embody Societal cultural values and align daily actions with departmental and company culture.
Education and Experience
- Bachelor’s degree in Microbiology, Bioengineering, or a related Life Science field.
- Knowledge of cGMP/FDA regulations.
- Knowledge of laboratory procedures, including the use and preparation of solutions, chemicals, and reagents.
- At least 3 years of experience specifically in aseptic filling and sterile operations.
- Ability to pass full aseptic gowning qualification and work in a cleanroom environment for extended periods.
- Strong technical writing and communication skills.
- Strong interpersonal skills and the ability to work effectively in a team environment.
- Ability to react quickly to changes in project priorities and timelines.
- Proficiency in the Microsoft Office suite, including Word, Excel, and Outlook.
- Understanding of electronic document management systems.
Benefits vary by client and are confirmed at the time of offer. Examples may include:
- Medical, dental, and vision insurance
- Life insurance
- Disability insurance
- 401(k)
- Paid time off (PTO)