Manufacturing Supervisor, Filling/Capping (2nd Shift)

Carlo Hefti AG; Bloomington (IN); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Manufacturing Supervisor to lead a dynamic team in the production of sterile injectable products. This pivotal role involves ensuring compliance with stringent cGMP standards, mentoring staff, and driving continuous improvement initiatives. You will be at the forefront of maintaining high-quality manufacturing processes while fostering a collaborative environment that emphasizes safety and productivity. If you are passionate about quality and leadership in a fast-paced setting, this opportunity is perfect for you to make a significant impact in the biopharmaceutical field.

Benefits

Medical & Dental Coverage

401(k) Retirement Savings Plan with Company Match

Flexible Spending Accounts

Paid Time Off

Education Assistance Program

Employee Assistance Program

Community and Volunteer Service Program

Onsite Workout Facility

Onsite Cafeteria

Adoption Reimbursement Program

Qualifications

• Minimum 2 years of manufacturing experience required.
• Leadership experience of at least 1 year is essential.
• Strong understanding of cGMP and safety regulations.

Responsibilities

• Supervise daily production and ensure compliance with cGMP.
• Interview, hire, mentor, and develop staff effectively.
• Implement training programs for staff on manufacturing processes.

Skills

Good Manufacturing Practices (cGMP)

Leadership

Root Cause Analysis (RCA)

Communication

Problem Solving

Education

High School diploma or GED

Bachelor's Degree

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

Maximo

Trackwise

Microsoft Dynamics

Job description

Manufacturing Supervisor, Filling/Capping (2nd Shift)

Bloomington, Indiana, United States

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging.

The role:

The Supervisor, Manufacturing is a member of the Manufacturing Leadership Team and reports directly to the Manufacturing Manager. They provide direct support to Manufacturing personnel and engage in the production of injectable drug products. The Supervisor, Manufacturing provides decision-making and oversight to ensure compliance with all standard operating procedures and batch records. They must communicate effectively with manufacturing support departments (Quality, Technical Services, Engineering, etc.), multiple levels of management, and other customer support departments. The Supervisor, Manufacturing builds an environment where partnership, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Responsibilities:

• Understand and follow current Good Manufacturing Practices
• Provide guidance, support, direction and leadership through positive interactions with all personnel during daily operations.
• Interview, hire, mentor, and develop staff. Conduct annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
• Supervise the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities – to meet customer requirements including deadlines and quality standards. High percentage of Gemba (shop floor) presence.
• Review, approve, and manage documentation for batch and system records. Assist in the release of product for distribution. Assist in meeting product release time goals.
• Implement and support training programs designed to enable staff to consistently carry out all manufacturing processes with strict compliance to cGMPs and EHS regulations.
• Develop and implement performance measurement and internal auditing programs in order to routinely evaluate operation efficiency and quality. Implement changes as needed based on assessments.
• Lead technical reviews, investigations and process improvement projects. Provide manufacturing input into integration and validation of new equipment and processes.
• Resolve technical, material and cGMP problems that may impact project deadlines.
• Provide guidance and troubleshooting assistance as needed during a deviation in the process; applying Root Cause Analysis (RCA) tools when applicable.
• Obtain qualification to perform select critical operation processes.
• Represent the company during audits and inspections.
• High School diploma or GED required
• Bachelor's Degree strongly preferred
• Minimum 2 years of manufacturing experience required
• Minimum 1 year leadership experience required
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Maximo, Trackwise, Microsoft Dynamics, etc.)

Physical / safety requirements:

• Ability to stand or sit for extended periods of time
• Ability to lift up to 50 pounds
• Ability to push/pull heavy wheeled objects (ie: tanks, carts, pallet jacks, etc.)
• Must be able to perform overhead work (ie: sanitizing walls and ceilings)
• Physical coordination/flexibility to allow gowning for clean room environments
• Use applicable personal protective equipment, including safety shoes/toe caps, gloves, eye protection, heat resistant wear and hearing protection
• Dexterity and physical condition to perform some level of repetitive motion tasks
• Ability to wear respirator usage when product or task requires
• Eyesight to ensure effective inspection of equipment and/or filled units (corrective lenses acceptable)
• Use of hands and fingers to manipulate office equipment is required
• Must be able to gown qualify for Grade A/B areas (filling)

In return, you’ll be eligible for:

• Medical & Dental Coverage
• Flexible Spending Accounts
• Life and AD&D Insurance
• Supplemental Life Insurance
  • Spouse Life Insurance
  • Child Life Insurance
• Short and Long-Term Disability Insurance
• 401(k) Retirement Savings Plan with Company Match
• Time Off Program
  • Paid Holidays
  • Paid Time Off
  • Paid Parental Leave and more
• Adoption Reimbursement Program
• Education Assistance Program
• Employee Assistance Program
• Community and Volunteer Service Program
• Additional Benefits
  • Voluntary Insurance Benefits
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
  • Onsite Campus Amenities
    • Workout Facility
    • Cafeteria
    • Credit Union

Disclaimer:

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.