Manufacturing Supervisor - 2nd Shift (PERM)
Weston, MA 02453
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Title: Manufacturing Supervisor
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
Pay rate: $92,500k
Job Location: Weston, MA
Job#: bh 13808
Manufacturing Supervisor Job Description with Mach Sok
The successful candidate will be responsible for the team’s production and quality goals. Applicants must have strong technical knowledge and problem-solving skills. Must be able to follow oral and written instructions accurately, learn complex tasks quickly, and complete tasks in a timely manner. Experience working in a GMP/ISO/document-controlled environment would be beneficial. Leadership skills, attention to detail, and the ability to work in a team environment are essential. Candidates must be willing and able to learn new manufacturing processes as the company grows.
- Contributes to the daily operation of the team, which will include the following:
- Fermentation using a 3000L bioreactor
- Product recovery using Microfiltration and Ultrafiltration
- Aseptic strain handling and liquid fill/finish within a Bio-safety cabinet
- Product recovery using tangential flow filtration
- Large scale buffer/media preparation
- pH precipitation
- Sterile filtration
- Aseptic liquid fill/finish
- Equipment cleaning (CIP/SIP)
- Timely and accurate completion/review of production documentation
- Entry of in-process data into trending databases
- May be required to cross train into Purification
- Maintain a safe working environment and follow all site safety procedures.
- Supervise direct reports which includes setting objectives
- Monitoring performance and promoting development plans.
- Train operators on production processes and ISO9001 Quality Management Systems
- Ensures all manufacturing processes are carried out according to approved batch records and SOPs
- Writes, revises and maintains SOPs, batch records and validation documents in accordance with policies
- Communicates with Quality Assurance and Materials Management to ensure raw materials are in place and released to prevent manufacturing interruptions
- May participate in project teams to develop, transfer, and scale up new manufacturing processes
- Support PM schedules, and coordinates with internal and external resources to ensure all equipment is calibrated and maintained as required
- Identifies process improvement opportunities and communicates such opportunities to management
- Reviews batch records for accuracy and in a timely manner. Reports deviations to Quality Assurance Participates in development and implementation of Corrective Actions
- Requires a BS in biology, chemistry or a related discipline with at least 4 years’ experience in the Biotech industry
- Demonstrated leadership skills, and ability to work in a team environment
- Excellent problem-solving skills
- Demonstrated experience and skill with process equipment, including plate washers and robotic dispensing systems
- Direct experience in validation of equipment and manufacturing processes
- Direct experience working within ISO9001 and/or GMP documentation and quality systems
- Experience in aseptic techniques and working in a laboratory setting
- Willing to work overtime as required
- Able to lift 25 lbs.
- Skilled in using ERP systems, Microsoft Excel, Word, Power Point, Outlook
- Excellent verbal and written communication
- Experience in LEAN manufacturing and 6 sigma a plus
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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