Manufacturing Technician II, Filling (Night Shift) Position Available In Chester, Pennsylvania

Job Description:

A career at Resilience is more than just a job – it’s anopportunity to change the future. Resilience is atechnology-focused biomanufacturing company that’s changing the waymedicine is made. We’re building a sustainable network ofhigh-tech, end-to-end manufacturing solutions to better withstanddisruptive events, serve scientific discovery, and reach those inneed. For more information, please visit www.resilience.comPosition Summary & Responsibilities The Manufacturing Technician IIis a direct labor position reporting to a Process Execution Team(PET) Manager on the Manufacturing floor, which supports Fillingoperations. This position will require working in variousControlled/Non-Classified and Classified areas. The FillingTechnician operates equipment, performs in-process monitoring, lineclearances, OEE data collection, cosmetic inspection, cleaning andcompletes batch record entries in accordance with cGMPs. JobResponsibilities Perform the duties of operating assigned machineryconsisting of servicing filling machines with materials, removingfinished materials from machine tables, and assuring the smoothflow of product. Responsible for assembling, disassembling,operating and sanitizing various Filling equipment. Perform andexecute filter integrity testing as needed per SOP. Performcleaning and housekeeping activities for assigned areas as requiredto maintain a cGMP environment. Be able to start up and make minoradjustments to machinery. Computer on-line may require some datainput. This includes SCADA and HMI entries. Perform visual andphysical checks of in-process and finished materials as requested.

Work with various printing devices including printing mats. Performbatch record and GMP documentation entries. Maintain records and/orlogs as required in the performance of job responsibilities. Thiswill include mathematical computation where needed. Knowledge ofproduct security controls and material handling equipment.

Responsible for outgoing quality level. Understand asepticbehaviors, media fills including line interventions, and have abasic knowledge of viable and non-viable monitoring equipment.

Perform inventory control and reconciliation activities, which mayrequire the use of SAP in a limited role. Perform work requirementsin a responsible manner, in accordance with SOPs, cGMPs andestablished safety procedures in accordance with OSHA requirementsand guidelines. Be familiar with “Material Safety Data Sheets” forarea chemicals. Be familiar with job-related safety procedures andhazards including PPEs, ergonomics, LOTO, human safety, materialhandling, waste handling, chemical handling, and spill controls.

Report all discrepancies to process facilitator. Assist mechanicalstaff with preventive maintenance procedures, as required. Supportlean activities and process improvement work such as performing 5Sin the work area and ,Single Minute Exchange of Die (SMED),participating in problem-solving, and manual tracking ofperformance data for OEE and process improvement analysis. Assistwith executing Validation/Engineering protocols forprocesses/equipment Identify and provide suggestions for processimprovement while maintaining quality and cGMP compliance asopportunities arise. Be flexible in training and support otherFilling functions as needed Perform all other assigned duties withminimal supervision under the direction of the process facilitatoror designee as needed. Acquire and maintain all requiredcertifications and qualifications for the assigned work area.

Minimum Requirements:

Must have the ability to effectivelyunderstand, read, write, communicate and follow instructions in theEnglish language. Good attention to detail is required. Individualmust be capable of keeping accurate records and performingmathematical calculations. Capable and motivated to learn newskills and develop new capabilities on an on-going basis tocontribute to the success of the Process Execution Team Ability towork effectively in a team environment Candidate should possess theability to work in and adapt to a changing/demanding environmentSome overtime may be required with minimal advance notice tosupport business needs Candidate must attain aseptic gowningqualification during training and be able to aseptically gown on aregular basis.

Preferred Requirements:

High school graduate,vocational school graduate or equivalent 1 Year of experience in apharmaceutical or cGMP regulated environment Prior productionexperience Experience working in a LEAN manufacturing environmentKnowledge of cGMPs and FDA policies/procedures The items describedhere are representative of those that must be met successfully toperform the essential functions of this job. Resilience is an EqualEmployment Opportunity Employer. Qualified applicants will receiveconsideration for employment without regard to race, color,religion, sex, sexual orientation, gender perception or identity,national origin, age, marital status, protected veteran status,disability status, physical or mental disability, geneticinformation, or characteristic, or other non-job-relatedcharacteristics or other prohibited grounds specified in applicablefederal, state, and local laws. Requests for reasonableaccommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards programincluding equity, an annual cash bonus program, a 401(k) plan witha generous company match and our benefits package which isthoughtfully designed to support our employees with greathealthcare (including medical, dental and vision), family buildingbenefits, life and disability insurance, flexible time off, paidholidays, other paid leaves of absence, tuition reimbursement andsupport for caregiving needs. Our target base pay hiring range forthis position is $21.50 – $32.00 per hour. Actual base pay isdependent upon a number of factors, including but not limited to,the candidate’s geographical location, relevant experience,qualifications, skills and knowledge. Excited about Resilience andthe biomanufacturing revolution? We encourage you to apply andstart a conversation with one of our recruiters. As a requirementof this role, employees must have the ability to demonstrate andmaintain gown qualification standards. Please review the videobelow, which outlines the most extensive process to gown withinspecific areas of Sterile Operations at Resilience, WestChester.