Packaging Operator - Shift 3

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.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

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

The 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.

• 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

The 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.

Desirable qualifications:

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

Physical /safety requirements:

• 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.

Additional requirements:

• 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.

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

• 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

• Employee Ownership Plan

• Additional Benefits

• Short and Long-Term Disability Insurance

• 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 12/31/26

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 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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