Senior Packaging Technician- 1st Shift

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.

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[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




• 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.

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