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.

 

#IND-USOPS
#LI-AD1

 


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

Reasonable Accommodations

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.

Data Privacy

To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:
https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

 

Apply for this Job

* Required

resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(File types: pdf, doc, docx, txt, rtf)


Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Simtra BioPharma Solutions’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.


Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.


Please reach out to our support team via our help center.
Please complete the reCAPTCHA above.