Create a Job Alert.

Enter your email below to save this search and receive job recommendations for similar positions.
Thank you. We'll send jobs matching these to
You already suscribed to this job alert.
No Thanks
US
What job do you want?

Sterile Manufacturing Manager job in Brooksville at The Staffing Resource Group, Inc

Create Job Alert.

Get similar jobs sent to your email

Apply to this job.
Think you're the perfect candidate?
Apply Now

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.
Sterile Manufacturing Manager at The Staffing Resource Group, Inc

Sterile Manufacturing Manager

The Staffing Resource Group, Inc Brooksville, FL Full Time
Apply Now

Create Job Alert.

Get similar jobs sent to your email

Title : Manufacturing Manager - Sterile
Location : Brooksville, FL
Type : Direct Hire
Schedule : M-F
Salary : Based on Experience

We are searching for a talented and motivated individual to fill the position of Manufacturing Manager in our clients team-oriented facility in the Tampa, Florida area.
Our client focuses on critical care, anesthesia and/or therapeutic areas and aiming to become a top producer in the injectable market in the United States. The goal is to provide supply chain security and reliability as a US based manufacture for essential medicines.


Responsibilities:
The employee should successfully meet schedules in a high quality and professional manner and ensure production/packaging areas and work areas conform to all safety and cGMP, Standard Operating Procedures and Corporate Policies.

This employee will supervise and assist technicians performing compounding, manufacturing, and packaging operations following approved Batch Records and routine troubleshooting and cleaning of complex equipment. Specifically, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs):

  • Completes production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems.
  • Ensures operation of equipment by calling for repairs; evaluating new equipment and techniques
  • Maintains safe and clean work environment by educating and directing personnel on the use of equipment, and resources; maintaining compliance with established policies and procedures.
  • Assist with training within the department
  • Act as a mentor to staff
  • Identify and correct problems
  • Identifies and implements continuous improvement
  • Perform on-the-job training of manufacturing technicians
  • Work as a cross-functional team member to coordinate manufacturing operations with Quality Control and Quality Assurance
  • Assist in equipment qualifications
  • Documentation
      • Complete all documentation as per procedures and policies and cGMP regulations
      • Review controlled documents such as batch records, sterilization and cleaning logs for accuracy and completeness
      • Writing Standard Operating Procedures, Validation Protocols, and Master Batch Records
      • Peer review for supporting departments
  • Provide necessary reports and assessments
  • Perform Risk Assessments and Deviation management in area of responsibility
  • Gowning qualification in IOS 5-8
  • The set-up, change-over, programming and operation of various aseptic processing equipment

Qualifications:
Education and Experience:

  • Bachelor of Science with 7-10 years experience in a cGMP regulated sterile manufacturing environment with at least 5 of those years in a lead/supervisor role.
  • Excellent knowledge of aseptic technique, trends in aseptic manufacturing, and manufacturing pearls for sterile batch production.
  • Computer skills in batch, QMS, HMI, and Office 365 required. Good verbal and written communication skills.
  • Good interpersonal and supervisory skills.

Physical:

  • Employees must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function
  • Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
  • Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).
  • Employees must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function.

Training:

  • Must successfully complete all departmental training and meet the requirements as part of ongoing training.
  • Must be able to act as trainer for all department training

Title: Manufacturing Manager - Sterile
Location: Brooksville, FL
Type: Direct Hire
Schedule: M-F
Salary: Competitive and Based on Experience

We are searching for a talented and motivated individual to fill the position of Manufacturing Manager in our clients team-oriented facility in the Tampa, Florida area. 
Our client focuses on critical care, anesthesia and/or therapeutic areas and aiming to become a top producer in the injectable market in the United States.  The goal is to provide supply chain security and reliability as a US based manufacture for essential medicines.


Responsibilities:
The employee should successfully meet schedules in a high quality and professional manner and ensure production/packaging areas and work areas conform to all safety and cGMP, Standard Operating Procedures and Corporate Policies. 

This employee will supervise and assist technicians performing compounding, manufacturing, and packaging operations following approved Batch Records and routine troubleshooting and cleaning of complex equipment.  Specifically, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs):

  • Completes production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems.
  • Ensures operation of equipment by calling for repairs; evaluating new equipment and techniques
  • Maintains safe and clean work environment by educating and directing personnel on the use of equipment, and resources; maintaining compliance with established policies and procedures.
  • Assist with training within the department
  • Act as a mentor to staff
  • Identify and correct problems
  • Identifies and implements continuous improvement
  • Perform on-the-job training of manufacturing technicians
  • Work as a cross-functional team member to coordinate manufacturing operations with Quality Control and Quality Assurance
  • Assist in equipment qualifications
  • Documentation
      • Complete all documentation as per procedures and policies and cGMP regulations
      • Review controlled documents such as batch records, sterilization and cleaning logs for accuracy and completeness
      • Writing Standard Operating Procedures, Validation Protocols, and Master Batch Records
      • Peer review for supporting departments
  • Provide necessary reports and assessments
  • Perform Risk Assessments and Deviation management in area of responsibility
  • Gowning qualification in IOS 5-8
  • The set-up, change-over, programming and operation of various aseptic processing equipment

Qualifications:  
Education and Experience:

  • Bachelor of Science with 7-10 years experience in a cGMP regulated sterile manufacturing environment with at least 5 of those years in a lead/supervisor role.
  • Excellent understanding of aseptic technique, trends in aseptic manufacturing, and manufacturing pearls for sterile batch production.
  • Computer skills in batch, QMS, HMI, and Office 365 required. Good verbal and written communication skills. 
  • Good interpersonal and supervisory skills.

Physical:

  • Employees must be able to lift or handle objects not more than 50 pounds to perform certain duties essential to the job function
  • Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
  • Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents (including potent compounds).
  • Employees must be able to wear a respiratory protection (filtering facepiece, 1/2 face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function.

Training:

  • Must successfully complete all departmental training and meet the requirements as part of ongoing training.
  • Must be able to act as trainer for all department training

Recommended Skills

Aseptic Techniques
Gmp
Injectable Products
Management
Sterile Manufacturing

Recommended Jobs

Sterile Manufacturing Manager
The Staffing Resource Group, Inc Brooksville Full Time
Entry Level Management & Operations
Tampa
$38,720 - $69,000/Year
Packing/ Assembler
Nesco Resource Lutz
$12.00 - $13.00/Hour
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team

CareerBuilder TIP

For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.