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PBS Biotech

Manufacturing Manager, Electromechanical Room Job at PBS Biotech in Camarillo

PBS Biotech, Camarillo, CA, United States


Job Description

Job Description

Company: PBS Biotech

PBS Biotech

Department:

       Manufacturing

Position/Title:

Manufacturing Manager, Electromechanical Room

Location:

Camarillo, CA

Reporting To:

Sr Director of Manufacturing

FLSA Status:

Exempt

Pay Range:

$124,626 - $150,459

 

GENERAL PURPOSE

We are seeking a motivated and eager-to-learn individual to join our team as a Manufacturing Manager Electro-Mechanical Room.

 

As a key part of our production team, you will be responsible for overseeing the workflow and ensuring the smooth operation of the electro-mechanical room. You will coordinate resources, monitor production timelines, and collaborate with other departments to meet production goals.

 

Responsibilities

Essential functions of the job are listed below.  Other responsibilities may also be assigned.  Please note that the essential functions may vary depending on department size, organizational structure and/or geographic location.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

 

Primary Responsibilities

 

·         Plan work assignments based on schedule to ensure maximum uptime of the area.

·         Respond to quality issues, material shortages and equipment malfunctions and find solutions to each.

·         Assess and implement operational improvements in the production floor

·         Ensure quality and safety procedures are followed and goals are met on a consistent basis.

·         Ensure all electromechanical room guidelines are strictly followed.

·         Keep accurate records of product produced and finish appropriate paperwork of operations related to manufacturing.

·         Review the manufacturing process and final output pieces to ensure all steps have been completed.

·         Maintain accurate production and inventory records to ensure accuracy and traceability.

·         Maintain, report and provide updates on KPI and goals for the Electromechanical Room.

·         Coordinate the training of electro-mechanical assemblers and supporting daily activity of operations, as needed.

·         Interface with other departments as required ensuring all department and company goals are achieved.

·         Oversee electromechanical room workers by inspecting their work; ensure orders are completed, inspected, tested, packed, and shipped on time and that all work is completed in accordance with the company's quality guidelines, corporate safety program and standard operating procedures.

 

·         Maintain all production equipment ensuring that regular maintenance requirements are completed and documented according to the company's operating procedures.

·         Generate NCRs relevant to Production.

·         System Owner for the Process Control Procedure

·         Approver of Change Records, NCRs and CAPAs

·         Representative to Change Record, NCR and CAPA meetings.

·         Lead (prepare and deliver) mid-year and annual performance reviews for reporting staff.

·         Coordinate Electromechanical Room PM, CM, EM and shutdowns with Facility Manager and QA

·         Motivating, supporting and providing guidance to production staff

·         Coordinate Electromechanical Room supplies

·         Hire new staff as needed

 

Minimum Qualifications

The following are the minimum qualifications that an individual needs in order to successfully perform the duties and responsibilities of this position.  Please note that the minimum qualifications may vary based upon the department size and/or geographic location.

 

Knowledge/ Experience

·         Bachelor of Science in Engineering

·         3+ years of managing production processes and equipment issues

·         2+ years GMP experience

·         Lean/Six Sigma Greenbelt Certification

·         Validation (IQ/OQ/PQ) experience in generating and executing protocols and reports

·         Project leadership experience

·         Strong communication skills

·         Ability to prioritize tasks and meet deadlines

·         Problem-solving skills

·         2 years of supervisory experience

 

Skills/ Abilities Pertinent to This Position

 

  • Strong communication skills
  • High attention to detail and accuracy

·         Supervise, train, coach and motivate staff.

·         Microsoft Office is required

·         Excellent organizational and time management skills

PHYSICAL DEMANDS

In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job.

 

Must be able to see, hear, speak and write clearly in order to communicate with employees and/or vendors; manual dexterity required for occasional reaching and lifting of small objects, and operating manufacturing equipment.  Must be able to lift various weights as needed to meet job requirements.

 

WORK ENVIRONMENT

In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to allow differently-abled individuals to perform the essential functions of the job within the environment.

 

Occasionally exposed to moving mechanical parts, fumes, machine lubricants, airborne particles, vibration, and risk of electrical shock, high noise while in the manufacturing plant. Personal protective equipment (vision and hearing) used in plant.  Exposed to heat, humidity conditions during warm weather months.

Company Description
PBS Biotech improves the lives of patients by providing scalable single-use manufacturing solutions to the cell therapy industry that enable broader access to novel regenerative medicines. The Vertical-Wheel bioreactor provides our customers with a truly scalable platform that is optimized for cell therapy manufacturing requirements, which streamlines their process development and accelerates their time to market.

Company Description

PBS Biotech improves the lives of patients by providing scalable single-use manufacturing solutions to the cell therapy industry that enable broader access to novel regenerative medicines. The Vertical-Wheel bioreactor provides our customers with a truly scalable platform that is optimized for cell therapy manufacturing requirements, which streamlines their process development and accelerates their time to market.