Packaging Operator - Shift 3Bloomington, Indiana, United StatesSimtra 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-6:45AMThe responsibilities:Label, package, and document per written instructions Package product in boxes, cartons, syringes, vials, blistersCount materials/product to ensure accurate countApply labels to various componentsReplenish packaging materials to areas/work cells as directed by Group LeaderMonitor and document TOR (time out of refrigeration)Complete batch record protocol steps at the time of performanceInspect, verify and track Scan printed materials Manually examine printed materials and products to ensure specifications are met, including variable text printed on-lineVerify incoming materials for useInspect product/materials for defectsPerform bar code and systems challenges (as applicable) for equipment usedComplete end of batch reconciliation and count verificationRetrieve product samplesMonitor and ensure appropriate downtime and efficiency information is logged accuratelySet-up, tear down and clear Participate and assist with line clearance activitiesRemove batch related materials from production areaEnsure electronic inventory transactions for inventory tracking movement and material verification are completedClean and clear debris from all work areasDispose of rejects in the appropriate disposal area following reconciliationStage materials in the appropriate designated locationsEnter and verify information in logbooks, as neededApply representation samples to the batch records as requiredIndicate 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 PolicyScheduled weekend overtime will be requiredVisual acuity 20/20 with or without correct ive vision and ability to pass color blind testEnsure all safety practices are followed and keep area clean and clear of hazardsThe 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:Good communication skillsGood documentation skills, including legible handwritingGood interpersonal skillsBasic computer skillsBasic math skillsKnowledge of standard operating procedures, specifications, and job-specific training materialsRequires 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 gunPhysical /safety requirements:Occasional (0-33%) Walking, climbing stairs and ladders, overhead reaching and/or lifting, balancing, kneeling, crouching, crawlingLifting up to 38 lbsCarrying up to 30 lbsFrequent (34-66%) Sitting, standing, reaching forward, object handling, fingering, fine hand coordination, simple and firm hand grasping, operating controlsLifting and carrying up to 32 lbsPushing and pulling up to 16 lbsConstant (67-100 % ) Object handling, fingering, fine hand coordination, simple hand grasping, firm hand graspingFinal 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:Day One Benefits Medical & Dental CoverageFlexible Spending AccountsLife and AD&D InsuranceSupplemental Life Insurance Spouse Life InsuranceChild Life Insurance401(k) Retirement Savings Plan with Company MatchTime Off Program Paid HolidaysPaid Time OffPaid Parental Leave and moreAdoption Reimbursement ProgramEducation Assistance ProgramEmployee Assistance ProgramCommunity and Volunteer Service ProgramEmployee Ownership PlanAdditional Benefits Short and Long-Term Disability InsuranceVoluntary Insurance Benefits Vision CoverageAccidentCritical IllnessHospital Indemnity InsuranceIdentity Theft ProtectionLegal and moreOnsite Campus Amenities Workout Facility