Simtra BioPharma Solutions
Senior Packaging Technician- 1st Shift
Simtra BioPharma Solutions, Bloomington, Indiana, United States, 47401
5 days ago Be among the first 25 applicants
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 a very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring life‑changing medicines to patients worldwide.
The Packaging Validation Senior Technician supports the Senior TS Packaging Engineer and Validation Associates with printed materials and during validation activities. This position reports to the Manager, Packaging Validation.
What you’ll be doing:
Creates In‑House Master Label Documents and maintains these documents throughout the document lifecycle (revisions and retirement)
Maintains client artwork Masters and associated PSMDs throughout the document lifecycle (revisions and retirement)
Supports OCR investigation and document routing
Supports particle creation for challenge sets
Supports the TS Packaging Admin in routing documents as needed
Utilize various computer programs to accomplish validation activities and record information (MS Excel, MS Word, Trackwise, D365, ROBAR, Veeva, etc.)
What you’ll bring:
High School diploma or GED required.
Minimum 1 year relevant experience required in a pharmaceutical manufacturing environment.
Experience in defect trending and label creation preferred.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include Trackwise, D365, ROBAR, Veeva, etc.)
Physical / Safety Requirements
Must be able to climb and work from ladders.
Must be able to qualify for 20/25 corrected vision.
Duties will require occasional overtime work, including nights and weekends.
Use of hands and fingers to manipulate office equipment is required.
Position requires standing for long hours, but may involve walking or sitting for periods of time.
In return, you’ll be eligible for
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
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 12/31/24
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.
EEO is the Law
Pay Transparency Policy
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
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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 a very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring life‑changing medicines to patients worldwide.
The Packaging Validation Senior Technician supports the Senior TS Packaging Engineer and Validation Associates with printed materials and during validation activities. This position reports to the Manager, Packaging Validation.
What you’ll be doing:
Creates In‑House Master Label Documents and maintains these documents throughout the document lifecycle (revisions and retirement)
Maintains client artwork Masters and associated PSMDs throughout the document lifecycle (revisions and retirement)
Supports OCR investigation and document routing
Supports particle creation for challenge sets
Supports the TS Packaging Admin in routing documents as needed
Utilize various computer programs to accomplish validation activities and record information (MS Excel, MS Word, Trackwise, D365, ROBAR, Veeva, etc.)
What you’ll bring:
High School diploma or GED required.
Minimum 1 year relevant experience required in a pharmaceutical manufacturing environment.
Experience in defect trending and label creation preferred.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include Trackwise, D365, ROBAR, Veeva, etc.)
Physical / Safety Requirements
Must be able to climb and work from ladders.
Must be able to qualify for 20/25 corrected vision.
Duties will require occasional overtime work, including nights and weekends.
Use of hands and fingers to manipulate office equipment is required.
Position requires standing for long hours, but may involve walking or sitting for periods of time.
In return, you’ll be eligible for
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
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 12/31/24
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.
EEO is the Law
Pay Transparency Policy
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
#J-18808-Ljbffr