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.

Summary

The Packaging Operator works within the Finishing/Packaging Complex. They inspect, label, and package pharmaceutical products to meet client demand and expectations. They contribute to creating an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product. This position reports to the Finishing Supervisor.

Essential Duties and Responsibilities:

1. Label, package, and document per written instructions

• Package product in boxes, cartons, syringes, vials, blisters
• Count materials/product to ensure accurate count
• Apply labels to various components
• Replenish packaging materials to areas/work cells as directed by Group Leader
• Monitor and document TOR (time out of refrigeration)
• Complete batch record protocol steps at the time of performance

2. Inspect, verify and track

• Scan printed materials Manually examine printed materials and products to ensure specifications are met, including variable text printed on-line
• Verify incoming materials for use
• Inspect product/materials for defects
• Perform bar code and systems challenges (as applicable) for equipment used
• Complete end of batch reconciliation and count verification
• Retrieve product samples
• Monitor and ensureappropriate downtime and efficiency information is logged accurately

3. Set-up, tear down and clear

• Participate and assist with line clearance activities
• Remove batch related materials from production area
• Ensure electronic inventory transactions for inventory tracking movement and material verification are completed
• Clean and clear debris from all work areas
• Dispose of rejects in the appropriate disposal area following reconciliation
• Stage materials in the appropriate designated locations
• Enter and verify information in logbooks, as needed
• Apply representation samples to the batch records as required
• Indicate appropriate signals with HMI (human machine interface) to track clearance, set-up, time, etc.

4. Other

• Required to maintain attendance in accordance with the Bloomington Attendance Policy
• Scheduled weekend overtime will be required
• Visual acuity 20/20 with or without corrective vision and ability to pass color blind test
• Ensure all safety practices are followed and keep area clean and clear of hazards

Work Environment: Controlled pharmaceutical environment including wearing long sleeves, safety toe shoes, gloves and safety glasses. Ability to work in a team environment on a variety of automated and semi-automated packaging lines.

Qualification Requirements: To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals to perform the essential functions:

• Good communication skills
• Good documentation skills, including legible handwriting
• Good interpersonal skills
• Basic computer skills
• Basic math skills
• Knowledge of standard operating procedures, specifications, and job-specific training materials
• Requires the operations of multiple types of equipment related to the packaging operations as well as hand operated equipment including, but not limited to, such things as barcode scanners, scales and tape gun

Education and Experience: High school diploma or GED required, 6 months of previous Pharmaceutical or Manufacturing experience preferred.

Language Skills: Must be able to understand, speak, read and write English in order to comply with necessary SOP', job-specific training materials, GMP's, and other manuals.

Physical Demands

• Occasional (0-33%)
• Walking, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawling
• Lifting up to 38 lbs
• Carrying up to 30 lbs
• Frequent(34-66%)
• Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controls
• Lifting and carrying up to 32 lbs
• Pushing and pulling up to 16 lbs

Additional Requirement: Final candidates for Packaging Operator will be required to pass a post offer/pre-employment job placement examination which will test the physical capabilities to perform the essential functions of the job.

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 thelink 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