Specialist Ii, Manufacturing

1 week ago

West Chester Township, United States Resilience Full time

A career at Resilience is more than just a job - it‘s an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that‘s changing the way medicine is made. We‘re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

For more information, please visit www.resilience.com

Position Summary & Responsibilities
This position: Specialist II, Manufacturing, performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include assisting with manufacturing investigations; issuance, revision, and authoring of documents; maintaining team production metrics for shift. The position provides oversight, execution, and approval for transactions in SAP and EDMS/QMS system (Veeva) as well as ensuring that Manufacturing Batch OEE performance data is collected as specified for each operating area.

* Maintain an advanced knowledge of the SAP system and execute SAP transactions as requiredto complete process orders.
* Daily and weekly coordination of activities to ensure production schedule is met.
* Technical writing to include investigations, line assessments, and corrective actions.
* Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable.
* Communicate policies and procedures to employees.
* Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
* Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (MasterBatch Records).
* Lead training on all document modifications prior to effective date.
* Initiate appropriate action when process deviations occur via Veeva IDM. Report processdeviations when they occur.
* Investigate manufacturing deviations; close out deviations, CAPAs and/or AFCAs as needed.
* Review completed production documentation (for example: batch records, log books, and so on) for quality, completeness, and cGMP compliance.

* Author/Approve/Review/Revise/Audit SOPs, Work Instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
* Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on.

* Read technical publications and manuals and write associated procedures.
* Complete required training.
* Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerptsfrom technical documentation.

* Create training modules and/or resources to ensure that SOPs (Standard Operating Procedures) are covered.

* Monitor training of employees to ensure compliance.
* Gather, organize, and communicate operational information to others.
* Lead process improvement activities and teams to meet strategic goals.
* Monitor key performance indicators to meet strategic goals.
* Perform quality audits and walk-throughs to check calibration tags, eye wash station, anythinglabelled, floors, and so on.
* Attend inter-departmental meetings to discuss matters involving the coordination of multipledepartments.
* Wear PPE (Personal Protective Equipment) as required by specific area oractivities.


Minimum Qualifications
1. Experience in documentation in a cGMP environment.
2. Experience in a pharmaceutical or cGMP regulated environment.
3. Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.

4. Good attention to detail is required. Individual must be capable of keeping accurate records.

Preferred Qualifications
1. Experience in a production environment.
2. High school graduate, vocational school graduate or equivalent, Bachelor‘s degree or equivalent.
3. Experience working in a LEAN manufacturing environment.

4. Knowledge of cGMPs and FDA policies/procedures.

The items described here are representative of those that must be met successfully to perform the essential functions of this job.

Resilience is an Equal Employment Opportunity Employer. Qualified applicants will receive consideration 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, genetic information, or characteristic, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state, and local laws. Requests for reasonable accommodation can be made at any stage of the recruitment process.

Resilience offers employees a robust total rewards program including equity, an annual cash bonus program, a 401(k) plan with a generous company match and our benefits package which is thoughtfully designed to support our employees with great healthcare (including medical, dental and vision), family building benefits, life and disability insurance, flexible time off, paid holidays, other paid leaves of absence, tuition reimbursement and support for caregiving needs. Our target base pay hiring range for this position is $28.50 - $43.00 per hour. Actual base pay is dependent upon a number of factors, including but not limited to, the candidate‘s geographical location, relevant experience, qualifications, skills and knowledge. Excited about Resilience and the biomanufacturing revolution? We encourage you to apply and start a conversation with one of our recruiters.

  • Specialist II, Manufacturing, Process Coordinator

    1 month ago

    West Chester, United States Resilience Full time

    A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and...

  • Manufacturing Technician II, Filling Operations Specialist

    3 weeks ago

    West Chester, Ohio, United States Resilience Corp. Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Technician II to join our team at Resilience Corp. in a Filling Operations Specialist role.The successful candidate will be responsible for operating and maintaining filling equipment, performing in-process monitoring, and ensuring the smooth flow of product.This is a direct labor position reporting to...

  • Manufacturing Engineer II

    4 weeks ago

    West Chester, Pennsylvania, United States Jabil Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineer II to join our team at Jabil. As a key member of our engineering team, you will be responsible for designing, developing, and implementing manufacturing processes and systems that meet our customers' needs.Key ResponsibilitiesDesign and develop manufacturing processes and systems to improve...

  • Manufacturing Engineer II

    4 weeks ago

    West Chester, Pennsylvania, United States Regal Rexnord Full time

    Job SummaryWe are seeking a highly skilled Manufacturing Engineer II to lead process improvements in our manufacturing cells associated with the Assembly and Machine Shop production lines.Key ResponsibilitiesLead process improvements in manufacturing cells to maximize product yield and throughputMaintain safe and reliable manufacturing processesDesign and...

  • Manufacturing Technician II, Parts Preparation Specialist

    3 weeks ago

    West Chester, Ohio, United States Resilience Corp. Full time

    Job SummaryResilience Corp. is seeking a skilled Manufacturing Technician II to join our team in a dynamic and fast-paced biomanufacturing environment. As a key member of our production team, you will be responsible for operating and maintaining complex equipment, ensuring the highest quality standards are met, and contributing to the company's mission to...

  • Manufacturing Specialist

    4 weeks ago

    West Kingston, RI, United States Modine Manufacturing Company Full time

    At Modine Manufacturing Company, we are committed to engineering a cleaner, healthier world. Our Climate Solutions and Performance Technologies segments support this purpose by improving air quality, reducing energy and water consumption, lowering harmful emissions, and enabling cleaner running vehicles and environmentally-friendly refrigerants.**Job...

  • Manufacturing Technician II, Filling Operations Specialist

    3 weeks ago

    West Chester, Ohio, United States Resilience Corp. Full time

    A career at Resilience Corp. offers a unique opportunity to contribute to the biomanufacturing revolution.The company is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific...

  • Manufacturing Technician

    7 days ago

    West Chester Township, United States Resilience Full time

    A career at Resilience is more than just a job - it‘s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that‘s changing the way medicine is made. We‘re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and...

  • Manufacturing Technician II

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job SummaryWe are seeking a skilled Manufacturing Technician II to join our team at Biogen. This role will involve providing customer-oriented service and support in a fast-paced manufacturing environment.The successful candidate will have a solid understanding of manufacturing systems, including mechanical, electrical, and control principles. They will be...

  • Manufacturing Engineering Manager II

    3 weeks ago

    West Chester, Pennsylvania, United States Regal Rexnord Corp Full time

    Job Summary:This position will lead the Global Manufacturing Design Engineering team at Regal Rexnord Corporation, responsible for delivering on-time Design for manufacturability and Assembly (DFM&A) processes with Line readiness & Equipment readiness to successfully Industrialize New Products.Key Responsibilities: Lead Manufacturing Readiness Level for...

  • Manufacturing Technician II

    5 months ago

    West Chester Township, United States National Resilience Full time

    A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and...

  • Manufacturing Technician II, Filling

    2 months ago

    West Chester, United States Resilience Full time

    A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and...

  • Manufacturing Technician II

    4 weeks ago

    Chester Springs, Pennsylvania, United States National Resilience Full time

    Job SummaryA career at Resilience offers a unique opportunity to be part of a revolutionary biomanufacturing company. As a Manufacturing Technician II, you will play a crucial role in the execution of batch activities on the manufacturing floor, ensuring the production of high-quality products.Key ResponsibilitiesMonitor process execution activities to...

  • Specialist Ii, Msat

    3 days ago

    West Chester Township, United States Resilience Full time

    A career at Resilience is more than just a job - it‘s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that‘s changing the way medicine is made. We‘re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and...

  • Manufacturing Operations Specialist

    4 weeks ago

    Chester, Virginia, United States Starplast USA Full time

    Job SummaryThe Manufacturing Operations Specialist will be responsible for assembling manufactured products and packing according to specifications. This role requires attention to detail and the ability to work efficiently in a fast-paced environment.Duties and ResponsibilitiesAssemble and package products to meet quality and quantity standards.Measure and...

  • Manufacturing Technician II-Packaging Line 5

    4 months ago

    West Chester Township, United States National Resilience Full time

    A career at Resilience is more than just a job – it’s an opportunity to change the future. Resilience is a technology-focused biomanufacturing company that’s changing the way medicine is made. We’re building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and...

  • Manufacturing Process Specialist

    3 weeks ago

    West Chester, Pennsylvania, United States Dover Corporation Full time

    Job Title: Manufacturing EngineerAbout the Role:We are seeking a skilled Manufacturing Engineer to drive manufacturing productivity and efficiency through analysis, design, and implementation of tools, processes, and equipment. The ideal candidate will have a strong background in mechanical or industrial engineering and experience in a manufacturing...

  • Manufacturing Quality Engineer II

    3 weeks ago

    West Boylston, Massachusetts, United States Coghlin Companies Full time

    Job DescriptionCogmedix, a subsidiary of Coghlin Companies, Inc., is seeking a highly skilled Manufacturing Quality Engineer II to join their team. As a key member of the manufacturing quality engineering department, this individual will be responsible for leading and executing daily manufacturing quality engineering efforts in support of manufacturing...

  • Engineer II

    2 days ago

    West Reading, PA, United States Carpenter Technology Full time

    Carpenter Technology Corporation is a leading producer and distributor of premium specialty alloys, including titanium alloys, nickel and cobalt based superalloys, stainless steels, alloy steels and tool steels. Carpenter's high-performance materials and advanced process solutions are an integral part of critical applications used within the aerospace,...

  • CNC Manufacturing Specialist

    4 weeks ago

    West Chester, Pennsylvania, United States LHH Full time

    CNC Manufacturing Technician RoleLHH Recruitment Solutions is seeking a skilled CNC Manufacturing Technician to join our client's team in the West Chester, PA region. The ideal candidate will have proven experience with CNC machines, including lathes, mills, and Swiss mills, as well as expertise in industrial applications.Key Responsibilities:Participate in...