CrawlJobs Logo

Aseptic Support Supervisor

fagron.com Logo

Fagron

Location Icon

Location:
United States , Wichita

Category Icon
Category:

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

Not provided

Job Description:

The Aseptic Support Supervisor is responsible for overseeing aseptic support operations within a 503B outsourcing facility, ensuring compliant execution of production activities that meet FDA, cGMP, and internal quality standards. This role provides daily leadership to aseptic support, staging, and coordination teams to ensure safe, accurate, and timely preparation of materials used in sterile manufacturing.

Job Responsibility:

  • Supervise aseptic support, staging support, and coordinator operations
  • Review operator adherence to HR policies and perform disciplinary action when necessary
  • Approve electronic time keeping for reports
  • Manage personnel to operational standards and complete performance evaluations
  • Partner with the new product development team to ensure components and batch records are ready to maintain adherence to the schedule
  • Review and maintain adherence to the manufacturing schedules
  • Aid in inventory control by ensuring personnel are properly documenting and consuming components and material in an ERP system
  • Track employee training to ensure compliance
  • Aid in bi-annual reviews of procedures
  • Provide on-the-floor leadership to the operational team
  • Ensure safety is followed with equipment, and certifications are up to date
  • Works with FSS2 staff to oversee transfers from FSS2 to FSS1

Requirements:

  • Demonstrated knowledge of cGMP pharmaceutical manufacturing, sterile production environments, and 503B regulatory expectations
  • Previous supervisory or lead experience in cleanroom, aseptic, or pharmaceutical operations preferred
  • Strong understanding of documentation practices, ERP systems, and material flow in regulated manufacturing environments
What we offer:
  • Competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry

Additional Information:

Job Posted:
April 05, 2026

Work Type:
On-site work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Aseptic Support Supervisor

Medical Assistant Lead - Oncology Radiology

Lead and provide exceptional patient experience by delivering friendly, prompt, ...
Location
Location
United States , Tucson
Salary
Salary:
Not provided
tmcaz.com Logo
Tucson Medical Center
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or general education degree (GED)
  • Two (2) years of medical assistance experience required
  • Medical Assistant Certificate
  • Basic Life Support (BLS) certification
  • Certified Medical Assistant (CMA) certification preferred
  • Knowledge of patient care protocols and practices
  • Knowledge of general patient care practice, methods and regulations
  • Skill in attending to patients with care and attention to needs
  • Skill in assisting with more complex patient care programs
  • Ability to lead, train and orient staff
Job Responsibility
Job Responsibility
  • Lead and provide exceptional patient experience by delivering friendly, prompt, and quality service to patients
  • obtain and secure patient information
  • prepare patients for examinations
  • counsel patients by transmitting physician orders
  • document medical information
  • provide basic patient care under the direction of the providers, management, and policies
  • serve as the point person for other medical assistants if they need help or further training
  • serve as the first point of clinical contact for the office
  • may supervise medical assistants and other support staff in the absence of supervisor
  • leads, trains, and supports medical assistant staff, orients new hires, and may supervise staff in the absence of supervisor
  • Fulltime
Read More
Arrow Right

Supervisor, Manufacturing

The Manufacturing Supervisor leads a manufacturing team in a variety of complex ...
Location
Location
United States , Bedford
Salary
Salary:
Not provided
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum High School Diploma
  • 5-7 years of experience in a GMPs environment required
  • 3-5 years of experience leading direct reports or teams is preferred
  • Experience with GMPs, FDA and other regulated agency environments is required
  • Experienced in making real time decisions on safety, process, scheduling and personnel-related issues.
  • Ability to prioritize and manage multiple resources in a production environment with flexibility to meet organizational needs
  • Proven leadership, persuasiveness, initiative, and problem solving skills
Job Responsibility
Job Responsibility
  • Ensure safety of manufacturing area and work practices in accordance with all PCI Health, Safety and Environmental program.
  • Be highly visible, hands-on team builder to motivate, coach, support, inspire and retain highly effective teams while managing for high performance and developing others
  • Coordinate and supervise Manufacturing personnel in the cGMP operations to meet all scheduled manufacturing work
  • Partner with Planning to ensure effective prioritization and schedule adherence and to meet all required capacity demands
  • Guide and train employees to ensure FDA and other regulatory agency requirements have been properly implemented and are continually met.
  • Plan and execute manufacturing instructions in order to perform equipment preparation, and fill activities for aseptic and non-aseptic products in accordance with Good Manufacturing Practices (GMP)
  • Collaborate with the other supervisors and enabling groups to optimize processes
  • Recruit and supervise staff to execute department functions
  • ensure effective utilization of resources through consistent performance management
  • Provide leadership, guidance, and direction to staff in alignment with cGMP requirements, department goals and corporate quality standards
  • Fulltime
Read More
Arrow Right

Operational Excellence Specialist

The Operational Excellence (OpEx) Specialist is a key driver of performance, com...
Location
Location
United States , Canton
Salary
Salary:
Not provided
fagron.com Logo
Fagron
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in Engineering, Life Sciences, Operations, or related field
  • 3+ years of experience in pharmaceutical manufacturing, ideally in a 503B, 503A, or cGMP sterile environment
  • Working knowledge of Lean, Six Sigma, and structured problem‑solving tools
  • Strong understanding of aseptic processing, sterile filtration, and cleanroom operations
  • Ability to analyze complex data sets and translate insights into actionable improvements
  • Excellent communication and facilitation skills
Job Responsibility
Job Responsibility
  • Lead and facilitate Lean initiatives (5S, standard work, visual management, value stream mapping) across ISO‑7 and ISO‑5 operations
  • Identify bottlenecks in compounding, filtration, filling, and inspection workflows
  • implement sustainable solutions that improve flow and reduce cycle time
  • Conduct time studies, labor modeling, and capacity analysis to optimize staffing and equipment utilization
  • Develop and maintain KPIs and dashboards that drive daily performance management
  • Lead structured problem‑solving (DMAIC, 5‑Why, Fishbone, Fault Tree) for deviations, complaints, and recurring operational issues
  • Partner with QA to ensure CAPAs are data‑driven, effective, and closed on time
  • Support investigations related to aseptic behavior, environmental monitoring trends, filter validation gaps, and equipment performance
  • Develop and refine SOPs, batch records, and work instructions to ensure clarity, consistency, and audit readiness
  • Translate complex technical requirements into technician‑friendly procedures without compromising compliance
What we offer
What we offer
  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry
  • Fulltime
Read More
Arrow Right

Supervisor, QC Microbiology, Second Shift

Life changing therapies. Global impact. Bridge to thousands of biopharma compani...
Location
Location
United States , Bedford
Salary
Salary:
Not provided
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Microbiology, Biology, or related life science (preferred)
  • Bachelor’s degree with 5+ years of progressive GMP QC Microbiology experience
  • 1–3+ years in a leadership role within a QC Microbiology lab
  • Hands-on experience with aseptic processing, environmental monitoring, and USP microbiological testing required
  • Skilled in data analysis and report writing
  • Must be able to work across NH PCI sites, including remote locations
  • Ability to gown for ISO-classified cleanroom work
  • Ability to lift up to 20 lbs
  • Occasional off-shift support may be required
Job Responsibility
Job Responsibility
  • Lead daily lab operations—including oversight of environmental monitoring, microbial testing of utilities (USP <61>, <62>, <85>), and in-process/final product testing
  • Supervise, mentor, and develop a high-performing team of microbiologists and lab personnel
  • Manage scheduling, workloads, and ensure timely testing and release of all microbiological samples
  • Perform risk assessments and investigations (EM excursions, aseptic incidents) and implement effective CAPAs
  • Perform data trending and statistical analysis
  • author quarterly reports on environmental and utility data
  • Oversee testing for endotoxins, bioburden, growth promotion, EM sampling, and clean utility sampling
  • Collaborate cross-functionally with Operations and Facilities to protect aseptic integrity
  • Support and coordinate equipment validation, calibration, and maintenance
  • Drive compliance with cGMP, FDA, EU, and international microbiology regulations
What we offer
What we offer
  • Opportunities for growth and advancement within a science-driven, patient-focused organization
  • A collaborative, team-oriented environment with cross-functional exposure
  • The chance to make an impact on public health by ensuring the safety of every batch
  • Ongoing training and development to keep your skills sharp in a fast-evolving industry
  • Fulltime
Read More
Arrow Right

Aseptic Support Technician - 2nd Shift

The primary responsibility of the Aseptic Support Technician is to prepare equip...
Location
Location
United States , Wichita
Salary
Salary:
Not provided
fagron.com Logo
Fagron
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent
  • Capable of lifting up to 50 pounds, standing for extended periods of time and shall have no allergies to chemicals that might be used during compounding or decontamination
  • Knowledge of cleanroom procedures, preferred but not required
  • Ability to work with others in a positive and professional manner and to develop and maintain strong working relationship with co-workers and management
Job Responsibility
Job Responsibility
  • Processes incoming material and equipment into the cleanroom through manual decontamination using approved cleaning agents and aseptic technique
  • Monitor BOMS as they move into the Cleanroom, following SOP and guidelines
  • Stocks cleanroom with supplies and chemicals
  • Helps perform inventory counts as needed
  • Informs supervisor of any problems that may arise
  • Ensures dispensing rooms are maintained, stocked, and tidy
  • Clock in and out for every scheduled shift in a timely manner
  • Other duties as assigned
What we offer
What we offer
  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry
  • Fulltime
Read More
Arrow Right

Aseptic Support Technician

The primary responsibility of the Aseptic Support Technician is to prepare equip...
Location
Location
United States , Wichita
Salary
Salary:
Not provided
fagron.com Logo
Fagron
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent
  • Capable of lifting up to 50 pounds, standing for extended periods of time and shall have no allergies to chemicals that might be used during compounding or decontamination
  • Knowledge of clean room procedures, preferred but not required
  • Ability to work with others in a positive and professional manner and to develop and maintain strong working relationship with co-workers and management
Job Responsibility
Job Responsibility
  • Processes incoming material and equipment into the cleanroom through manual decontamination using approved cleaning agents and aseptic technique
  • Monitor BOMS as they move into the Cleanroom, following SOP and guidelines
  • Stocks cleanroom with supplies and chemicals
  • Helps perform inventory counts as needed
  • Informs supervisor of any problems that may arise
  • Ensures dispensing rooms are maintained, stocked, and tidy
  • Clock in and out for every scheduled shift in a timely manner
  • Other duties as assigned
What we offer
What we offer
  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry
  • Fulltime
Read More
Arrow Right

Aseptic Support Technician

The primary responsibility of the Aseptic Support Technician is to prepare equip...
Location
Location
United States , Wichita
Salary
Salary:
Not provided
fagron.com Logo
Fagron
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High school diploma or equivalent
  • Capable of lifting up to 50 pounds, standing for extended periods of time and shall have no allergies to chemicals that might be used during compounding or decontamination
  • Ability to work with others in a positive and professional manner and to develop and maintain strong working relationship with co-workers and management
Job Responsibility
Job Responsibility
  • Processes incoming material and equipment into the cleanroom through manual decontamination using approved cleaning agents and aseptic technique
  • Monitor BOMS as they move into the Cleanroom, following SOP and guidelines
  • Stocks cleanroom with supplies and chemicals
  • Helps perform inventory counts as needed
  • Informs supervisor of any problems that may arise
  • Ensures dispensing rooms are maintained, stocked, and tidy
  • Clock in and out for every scheduled shift in a timely manner
  • Other duties as assigned
What we offer
What we offer
  • competitive salary
  • comprehensive benefits
  • performance package
  • ability to be part of an international leader in an expanding industry
  • Fulltime
Read More
Arrow Right

Senior Manager, Engineering, Maintenance & Facilities

The senior manager is accountable for all aspects of Engineering, Instrumentatio...
Location
Location
United States , Madison
Salary
Salary:
Not provided
pci.com Logo
PCI Pharma Services
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in engineering discipline preferred
  • Master’s degree in engineering or business administration preferred
  • Operational background in cGMP environment, preferably in aseptic manufacturing/engineering
  • Demonstrated skill in managing a diverse population of professional, technical, and hourly personnel as well as external resources
  • Experience in working with regulators during inspections/audits is highly desired
  • 8+ years of experience in the field of technical engineering support to biopharma/pharm and/or medical device facilities
  • 8-10 years of experience in management of professional and technical staff with accountability for objectives and subsequent evaluation
  • 5-8 years of experience with engineering and maintenance support to biopharma/pharm and/or medical device facilities
  • 5 years of experience managing subordinate people leaders with accountability for objectives and subsequent evaluation
  • Experience with company financial systems and an understanding of accounting practices and financials a plus
Job Responsibility
Job Responsibility
  • Accountable for all aspects of Engineering, Instrumentation and Controls, Metrology, Utilities, Facilities, and Maintenance in supporting pharmaceutical product manufacturing across the PCI Madison, WI site
  • Provides leadership to ensure the highest level of quality and adherence to cGMPs across the site
  • Responsible for managing people, providing quality and technical direction, and actively participating in driving and developing strategies for continuous improvement within the department
  • Manages and oversees all areas of process engineering, automation, calibration, facilities, operation of utilities including HVAC, buildings and ground maintenance, and maintenance of utilities and facilities supporting aseptic operations
  • Responsible for management of site CAPEX projects and acts as site representative for PCI’s Environmental, Social, and Governance program
  • Ensures all aspects of engineering and facilities are adhering to cGMPS and PCI’s established SOPs
  • Ensures all projects are executed safely, on time, and within budget
  • Identifies, prepares and leads site CAPEX projects
  • Determine appropriate equipment, line, tooling, costs and capacities for new projects or changes to existing projects
  • Instill a strong culture of Lean and Continuous Improvement through the use of the site maturity index
  • Fulltime
Read More
Arrow Right