For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
Your role at Simtra BioPharma Solutions:
The Manufacturing Trainer is a member of the Manufacturing Team reporting directly to the Lead Trainer Manufacturing. They provide direct support to manufacturing personnel to ensure Good Manufacturing Practices (GMP) and core competencies are met. The Manufacturing Trainer provides oversight to ensure compliance to all regulatory agency regulations and guidelines and to Standard Operating Procedures. The manufacturing trainer must be able to manage time effectively, build efficiency into the training process, and have a desire to improve processes. 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.
What you'll do:
- Ability to effectively train employees on manufacturing core curriculum, highly focused on OJT (on the job training)
- Support supervisors in all aspects of the department related to training, (creation and deployment of training policies, processes, and documents, etc.)
- Facilitate personnel allocation discussions with leadership ensuring appropriately trained personnel are completing tasks and opportunity for training and growth is provided
- Assist with creation of training tools/manuals/job aids for operators to enhance performance
- Deliver feedback (and re-training as needed) to team members about their performance in a positive manner that fosters teamwork
- Seek feedback from team members to continually improve the training process and program
- Perform real-time documentation review of in-process manufacturing activities while coaching GDP principles
- Participate on continuous improvement teams
- Ensure personnel are completing training documentation appropriately
- Write, revise and review pertinent documentation as appropriate
- Create and maintain competency depth assessments for assigned shift and/or department
- Work with other departments as necessary to create training programs that reinforce and educate employees on the importance of having a Quality focus in daily work
- Maintain personal qualifications to provide production support as needed
- Provide classroom training as needed
What you'll bring:
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: JDE, BPLM, Pilgrim, Trackwise, BaxU, 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.
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
Equal Employment Opportunity
Simtra is 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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
Simtra is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.