Packaging Operator - Shift 3

Simtra BioPharma Solutions•Bloomington, IN

1d•Onsite

About The Position

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled 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, there is a strong emphasis on quality and continuous improvement at Simtra. 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. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide. This role: 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. Shift 3 Hours: 10:45PM-6:45AM

Requirements

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.
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
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
Constant (67-100%) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand grasping
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.
High School diploma or GED required
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.

Nice To Haves

6 months of previous Pharmaceutical or Manufacturing experience preferred.

Responsibilities

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
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 ensure appropriate downtime and efficiency information is logged accurately
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.