Manufacturing Technician IV, Packaging Lead (Nights)

BioSpace; Olde West Chester (OH); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biomanufacturing company seeks a Manufacturing Technician IV, Packaging Lead for night shifts. The role involves overseeing operations on the manufacturing floor, ensuring documentation compliance, and contributing to continuous improvement projects. Preferred candidates have experience in GMP environments and a high school education or equivalent.

Benefits

Annual cash bonus program

401(k) plan with company match

Generous healthcare benefits

Flexible time off

Qualifications

• Experience in a GMP environment is required.
• Good attention to detail and communication skills are essential.
• Experience in a pharmaceutical or high-speed packaging production environment is preferred.

Responsibilities

• Lead daily Tier 1 meetings and assign tasks to technicians.
• Manage batch documents and ensure compliance with GMP.
• Resolve production-related issues during operations.

Skills

Attention to detail

Communication

Problem-solving

Education

High school graduate or equivalent

Tools

SAP

Microsoft applications

Veeva Vault

Job description

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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

Brief Job Description

The Lead Technician reports to a Manager/Supervisor on the Manufacturing floor, which supports Packaging operations. This position will require working in various Controlled/Non-Classified areas. The Lead Technician leads the execution of batch activities on the manufacturing floor, which includes leading daily Tier 1 meetings, assigning daily tasks to production technicians, managing batch documentation, and coordinating production tasks and turnover activities. In addition, the Lead Technician will execute training for Packaging Technicians, conduct batch reconciliation and accountabilities per cGMPs, and perform the role of a Packaging Technician as needed. The Lead Technician will also serve as a resource for the implementation of continuous improvement projects.

Primary Responsibilities

• Lead and monitor process execution activities to ensure successful operations on the production floor. Typical duties include leading daily Tier 1 meetings, assigning daily tasks to production technicians, monitoring material and supply levels, and coordinating production tasks such as batch execution and turnover activities.
• Act as a first-line resource for the team. Provide support to production technicians and mechanic technicians. Resolve production-related issues such as batch set-up, execution, technical intervention, documentation, equipment operations, line SOPs, and safety and quality inspection procedures.
• Perform inventory control and reconciliation activities, which will require the use of SAP and WES in a limited role.
• Perform technician tasks as required including start-up, equipment operation, manual packaging, batch execution, material handling, rework, quality inspection, cleaning, housekeeping and line clearance activities.
• Manage batch records and GMP documentation on the production floor. Review documentation for completeness and accuracy per GxP standards within established timelines. Assist and train others to complete documentation as required.
• Be familiar with job-related safety procedures and hazards including PPEs, ergonomics, LOTO, human safety, material handling, chemical handling, and spill controls.
• Ensure work requirements are followed on the production floor, in accordance with SOPs and established safety and quality procedures.
• Work alongside Process Facilitators and Engineers, creating an collaborative environment for all Packaging associates.
  
  
  

Other Responsibilities

• Support lean activities such as performing 5S in the work area, participating in problem-solving, and manual tracking of performance data for OEE and process improvement analysis. Lead Level 0 problem-solving on process related issues and generate OPL communications as needed.
• Act as a certified OJT trainer on the team on assigned equipment and process tasks. Train and conduct evaluations on other team members for training qualifications.
• Review process documents such as operational SOPs, forms and batch records for accuracy. Identify and provide suggestions for process improvement while maintaining quality and cGMP compliance as opportunities arise.
• Execute protocols as required as a part of equipment qualification and process validation work
• Be flexible and support other work areas within the Team as needed

• Perform all other assigned duties with minimal supervision under the direction of the process facilitator or designee as needed.
• Minimum Requirements:
• Must have the ability to effectively understand, read, write, communicate and follow instructions.
• Good attention to detail is required.
• Individual must be capable of keeping accurate records and performing mathematical calculations
• Experience working in a GMP environment
• Preferred Background:
• Experience in a pharmaceutical or high speed packaging production environment
• High school graduate, vocational school graduate or equivalent
• Working knowledge of Microsoft applications, SAP and Veeva Vault
• Experience working in a LEAN manufacturing environment
• Knowledge of cGMPs and FDA policies/procedure
  

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 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 $26.00 - $40.50 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.

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Management and Manufacturing

• Industries

  Internet News

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