Manufacturing Trainer- Aseptic Filling (1st Shift)

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:

As a Manufacturing Trainer, you will play a critical role in ensuring operational excellence and compliance on the production floor by empowering team members through effective training. . You will provide training and support to manufacturing personnel to ensure Good Manufacturing Practices (GMP) and core competencies are met. The Manufacturing Trainer also provides oversight to ensure compliance to all regulatory agency regulations and guidelines and to Standard Operating Procedures. The manufacturing trainer must be able to:

Communicate effectively and efficiently

manage time effectively

build efficiency into the training process

Give and take feedback

The ideal candidate will be vested in their own personal growth and excited to support the growth of others. 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 Manufacturing Trainer creates an environment where teamwork, productivity, safety, identity, strength, purity, and quality (SISPQ) are reflected in the finished product.

The responsibilities:

Training Delivery & Development

Train employees on core manufacturing curriculum with a focus on OJT (on the job training).

Create training tools, manuals, and job aids to enhance operator performance.

Provide classroom training as needed.

Deliver feedback (and re-training as needed) to team members about their performance in a positive manner that fosters teamwork

Compliance & Documentation

Review in-process documentation and coach GDP principles.

Ensure accurate completion of training records.

Write, revise, and review SOPs and training documents.

Continuous Improvement & Collaboration

Seek feedback to improve training programs.

Participate in continuous improvement initiatives.

Facilitate personnel allocation discussions with leadership.

Maintain personal qualifications to provide production support as needed

Required qualifications:

High School Diploma or GED required.

Minimum of 1 year experience required in Pharmaceutical Manufacturing.

1 year of leadership or training experience preferred.

Strong communication and interpersonal skills.

Ability to provide effective group and individual training.

Experience in technical writing preferred.

Willingness to build efficiency into training processes and manage time effectively.

Demonstrated desire to continually learn.

Knowledge of cGMP and GDP practices required.

Proficiency in a variety of mathematical disciplines and ability to work with both the metric and USA standards of measurement required.

Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: D365, Veeva, Pilgrim, Trackwise, Absorb, etc.)

Physical / safety requirements:

Ability to stand 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.).

Utilize 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)

Duties may require overtime work, including nights and weekends

Use of hands and fingers to manipulate office equipment is required.

In return, you'll be eligible for[1]:

Day One Benefits

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

Employee Ownership Plan

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

[1] Current benefit offerings are in effect through 12/31/25

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.

Equal Employment Opportunity

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.

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