Manufacturing Technician II – Sterile Filling 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.com

Position Summary:

The Manufacturing Technician II is a direct laborposition reporting to a Process Execution Team (PET) Manager on theManufacturing floor, which supports Filling operations. Thisposition will require working in various Controlled/Non-Classifiedand Classified areas. The Filling Technician operates equipment,performs in-process monitoring, line clearances, OEE datacollection, cosmetic inspection, cleaning and completes batchrecord entries in accordance with cGMPs. This is a Day (B) Shift,12-

Hour Rotating Schedule Position Responsibilities:

Perform theduties of operating assigned machinery consisting of servicingfilling machines with materials, removing finished materials frommachine tables, and assuring the smooth flow of product.

Responsible for assembling, disassembling, operating and sanitizingvarious Filling equipment. Perform and execute filter integritytesting as needed per SOP. Perform cleaning and housekeepingactivities for assigned areas as required to maintain a cGMPenvironment. Be able to start up and make minor adjustments tomachinery. Computer on-line may require some data input. Thisincludes SCADA and HMI entries. Perform visual and physical checksof in-process and finished materials as requested. Work withvarious printing devices including printing mats. Perform batchrecord and GMP documentation entries. Maintain records and/or logsas required in the performance of job responsibilities. This willinclude mathematical computation where needed. Responsible foroutgoing quality level. Understand aseptic behaviors, media fillsincluding line interventions, and have a basic knowledge of viableand non-viable monitoring equipment. Perform inventory control andreconciliation activities, which may require the use of SAP in alimited role. Perform work requirements in a responsible manner, inaccordance with SOPs, cGMPs and established safety procedures inaccordance with OSHA requirements and guidelines. Be familiar with”Material Safety Data Sheets” for area chemicals. Be familiar withjob-related safety procedures and hazards including PPEs,ergonomics, LOTO, human safety, material handling, waste handling,chemical handling, and spill controls. Report all discrepancies toprocess facilitator. Assist mechanical staff with preventivemaintenance procedures, as required. Support lean activities andprocess improvement work such as performing 5S in the work area and,Single Minute Exchange of Die (SMED), participating inproblem-solving, and manual tracking of performance data for OEEand process improvement analysis. Assist with executingValidation/Engineering protocols for processes/equipment Identifyand provide suggestions for process improvement while maintainingquality and cGMP compliance as opportunities arise. Be flexible intraining and support other Filling functions as needed Perform allother assigned duties with minimal supervision under the directionof the process facilitator or designee as needed. Acquire andmaintain all required certifications and qualifications for theassigned work area. Some overtime may be required with minimaladvance notice to support business needs

Minimum Qualifications:

Must have the ability to effectively understand, read, write,communicate and follow instructions in the English language. Goodattention to detail is required. Individual must be capable ofkeeping accurate records and performing mathematical calculations.

Capable and motivated to learn new skills and develop newcapabilities on an on-going basis to contribute to the success ofthe Process Execution Team Ability to work effectively in a teamenvironment Candidate should possess the ability to work in andadapt to a changing/demanding environment Candidate must attainaseptic gowning qualification during training and be able toaseptically gown on a regular basis.

Preferred Qualifications:

Highschool graduate, vocational school graduate or equivalent 1 Year ofexperience in a pharmaceutical or cGMP regulated environment Priorproduction experience Experience working in a LEAN manufacturingenvironment Knowledge of cGMPs and FDA policies/proceduresKnowledge of product security controls and material handlingequipment. Resilience is an Equal Employment Opportunity Employer.

Qualified applicants will receive consideration for employmentwithout regard to race, color, religion, sex, sexual orientation,gender perception or identity, national origin, age, maritalstatus, protected veteran status, disability status, physical ormental disability, genetic information, or characteristic, or othernon-job-related characteristics or other prohibited groundsspecified in applicable federal, state, and local laws. Requestsfor reasonable accommodation can be made at any stage of therecruitment process. Resilience offers employees a robust totalrewards program including equity, an annual cash bonus program, a401(k) plan with a generous company match and our benefits packagewhich is thoughtfully 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.