Manufacturing Engineer Manager jobs in Petersburg, VA

Benefits:

• 401(k)
• Competitive salary
• Dental insurance
• Health insurance
• Opportunity for advancement
• Paid time off

Job Description

The Manufacturing Manager will develop and support the Manufacturing team by participating in equipment qualifications, identifying and implementing process improvements through process monitoring, conducting investigations and impact assessments. Will provide new process training to the manufacturing team to achieve efficient, safe, and compliant production of quality injectable products according to the company culture and vision of what is in the best interest of the patient.

This is an exclusive listing.

Essential Duties and Responsibilities:

• Mentors, coaches, and teaches Manufacturing technicians to perform routine prep and filling activities for the cartridge line.
• Ensure that the Manufacturing organization operates to meet the requirements of approved production plans at minimum costs within established quality limits and in accordance with FDA, cGMP, ISO, and OSHA requirements.
• Develop and create standard operating procedures, specifications, and other forms of governing documents to delineate manufacturing process requirements according to qualification, compliance, and business requirements.
• Under the Director of Manufacturing’s direction, actively participate in new equipment and process qualifications.
• Responsible for identifying opportunities to improve customer service, quality, safety performance, scrap minimization by using effective project management, cost control techniques, and Lean Manufacturing.
• Utilizes scientific methods and statistical tools to perform investigations, root cause analyses, and impact assessments in support of timely resolution of deviations/discrepancies related to Manufacturing.
• Identify corrective and preventive actions (CAPA), lead project to completion within project timelines. Verify effectiveness of CAPA by post-project data collection and analysis.
• Use of statistical tools, Lean/Six Sigma methodologies, and change management/control techniques to ensure timely completion of projects at the expected results.
• Demonstrated ability to act as subject matter expert in manufacturing equipment build and function, as well as in manufacturing processes, including aseptic filling, isolator/RABs technology, and packaging.

Minimum Qualifications (Knowledge, Skills, and Abilities)

• Bachelor's degree with 8 years demonstrated ability in a cGMP production environment.
• Associate degree and 10 years of cGMP production experience or High School degree with 12 years of experience of cGMP production experience may be considered.
• Experience in a sterile fill finish facility.
• 2 years of supervisory experience.
• Demonstrated excellence in oral and written communication.

Preferred Qualifications:

• Experience with equipment qualification.
• Advanced experience in a process improvement environment including project management, change management and leading Lean/Six Sigma project teams.
• Lean Manufacturing/Six Sigma Green Belt Certification preferred.

Shift: 7:00 am – 3:30 pm. Monday through Friday.

Physical Demands and Work Environment:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.

While performing the essential duties of this position, the employee is regularly required to speak or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. The noise level in the work environment is usually low to moderate.

The company is an Equal Opportunity Employer, drug free workplace, and complies with ADA regulations as applicable.