Filling Group Leader (3rd Shift)

Simtrabps; Bloomington (IN); On-site; USD 55,000 - 75,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a Filling Group Leader for the 3rd shift. This role involves overseeing filling operations, ensuring compliance with quality standards, and fostering teamwork. Ideal candidates will have experience in aseptic manufacturing and strong communication skills. Join us to contribute to life-changing medicines and enjoy comprehensive benefits from day one.

Benefits

Medical & Dental Coverage

401(k) with Company Match

Paid Time Off

Parental Leave

Gym and Cafeteria

Qualifications

• Ability to work independently and communicate effectively.
• Knowledge of aseptic manufacturing practices and standard operating procedures.

Responsibilities

• Delegate and coordinate activities of assigned team members.
• Train and mentor team members while troubleshooting process problems.
• Maintain compliance with regulatory agency regulations.

Skills

Communication

Documentation

Interpersonal Skills

Basic Math Skills

Aseptic Manufacturing Practices

Education

High School Diploma or GED

Tools

Calipers

Scales

Gauges

Job description

Join to apply for the Filling Group Leader (3rd Shift) role at Simtra BioPharma Solutions

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.

Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra?

• Because we: Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.
• Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.
• Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.
• Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

This role:

The Filling Group Leader is a member of the Manufacturing Leadership Team reporting directly to the Manufacturing Supervisor. They provide direct support to manufacturing to ensure that finished products meet the required specifications by coordinating activities of Filling Operators who perform in the manufacturing areas. The Filling Group Leader provides decision-making and oversight to ensure compliance to all regulatory agency regulations and guidelines and to Simtra Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, and other customer support departments. The Filling Group Leader creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

1. Delegate, coordinate, and schedule activities of assigned team members.
2. Recommend measures to improve performance and increase efficiency.
3. Train and mentor other team members.
4. Troubleshoot process problems and respond to process alarms.
5. Participate on Continuous Improvement teams.
6. Assist in developing/reviewing batch records of new and existing projects.
7. Assist in establishing and orienting new projects for production.
8. Review project plans and batch records prior to operations; monitor assigned team’s documentation in logbooks and batch records.
9. Organize and coordinate general cleaning and sanitizations throughout all filling suites.
10. Identify potential causes and verify/eliminate each one to determine the true root cause behavior.
11. Maintain attendance in accordance with the Bloomington Attendance Policy.
12. Scheduled weekend overtime will be required.

The work environment:

Classified pharmaceutical environment wearing required gowning. Must be able to work safely with materials required to produce pharmaceutical products, including chemicals, compounds, glassware and sanitization solutions. Must be able to occasionally (1-33% of the time) work in a confined/clustered work space.

Desirable qualifications:

Requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:

• Ability to work independently.
• Good communication skills.
• Good documentation skills, including legible handwriting.
• Good interpersonal skills.
• Basic computer skills.
• Basic math skills.
• Knowledge of aseptic manufacturing practices.
• Knowledge of standard operating procedures, specifications, and job-specific training materials/Subject Matter Expert.
• Operation of multiple types of equipment related to manufacturing, including hand-operated equipment such as calipers, scales, gauges, and other measuring devices.

Physical / safety requirements:

• Occasional (1-33%): Sitting, climbing stairs and ladders, balancing, kneeling, operating controls, lifting and carrying up to 70 lbs, pushing and pulling up to 35 lbs.
• Frequent (34-66%): Standing, walking, reaching forward and overhead, stooping, crouching, lifting and carrying up to 37 lbs.
• Constant (67-100%): Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping.

Additional requirements:

• High school diploma or GED required.
• 6 months of previous Pharmaceutical or Manufacturing experience preferred.
• Final candidates will be required to pass a post-offer/pre-employment physical capabilities test.

In return, you’ll be eligible for:

• Day One Benefits including Medical & Dental Coverage, FSA, Life and AD&D Insurance, Short and Long-Term Disability, 401(k) with Company Match, Paid Holidays, Paid Time Off, Parental Leave, and more.
• Additional Benefits: Vision, Accident, Critical Illness, Hospital Indemnity, Identity Theft Protection, Legal, Employee Assistance, Community Service, Employee Ownership, and onsite amenities like a gym and cafeteria.

Disclaimer:

This job description provides the minimum knowledge, skills, and abilities necessary to perform the job and may not include all duties. Modifications may be made based on business needs.

Equal Employment Opportunity:

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

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