Manufacturing Technician IV, Lead - Inspection (Days)

Resilience; Port Union (OH); Sur place; USD 36 000 - 56 000; Plein temps

Avantages offerts par ce poste

Annual bonus

401(k) plan

Healthcare coverage

Paid vacation

Résumé du poste

Resilience, a technology-focused biomanufacturing company, seeks a Manufacturing Technician IV, Lead to supervise inspection activities on the production floor. You will review complex documents, ensure qualification standards, and drive continuous improvement with Process Facilitators and Engineers.

The role requires leadership, strong documentation skills, and deep knowledge of cGMPs. You will support lean initiatives, participate in daily Tier 1 meetings, and mentor junior technicians on

Qualifications

• Experience in pharmaceutical manufacturing with cGMP.
• Experience leading floor execution on inspection and manufacturing lines.
• Ability to read, write, speak English to communicate technical information.
• Strong organizational and problem-solving skills with the ability to prioritize operations.
• Team collaboration in a fast-paced production environment.

Responsabilités

• Lead and monitor inspection process activities on the production floor to ensure successful operations.
• Perform inspection activities and support floor coverage and qualification maintenance.
• Maintain batch records and GMP documentation on the production floor.
• Follow SOPs and cGMPs; ensure compliance and safety procedures.
• Provide technical guidance to team members and act as SME for inspection tasks.
• Participate in training, deviations, CAPA, and SOP revisions as needed.

Connaissances

Leadership

Documentation

cGMP

SAP

WES

Problem solving

English communication

Formation

High school diploma or equivalent

Outils

SAP

Veeva Vault

Description du poste

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

Manufacturing Technician IV, Lead

reports to a Supervisor/Manager on the Manufacturing floor and leads complex Inspection floor activities. The Technician serves as a technical resource for the team, performs advanced-level documentation review, maintains qualification standards, and drives continuous improvement in partnership with Process Facilitators and Engineers.

Job Responsibilities

Operations:

• Lead and monitor inspection process activities to ensure successful operations on the production floor.
• Perform inspection activities as needed to support floor coverage and qualification maintenance.
• Perform inventory control and reconciliation activities using SAP and WES.
• Execute protocols as required as part of equipment qualification and process validation work.
• Ensure work requirements are followed on the production floor in accordance with SOPs and cGMPs.
• Support lean activities including 5S, problem-solving, and serving as CI project resource for the Process Execution Team (PET).

Documentation & Compliance:

• Perform advanced-level batch record and GMP documentation entries on the production floor, including complex or non-routine documentation; provide guidance to team members on documentation accuracy.
• Access and print SOPs and forms via ECMS as required, using current revisions.
• Follow job-related safety procedures including PPE use, LOTO, ergonomics, and chemical handling.
• Use process documents including SOPs, forms, and batch records to guide own work in accordance with SOPs and cGMPs.

Training & Development:

• Maintain all required certifications and qualifications for the assigned work area.
• Serve as a technical resource for the team, providing subject-matter guidance to production and mechanical technicians.
• Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
• Support team members in maintaining required qualifications and certifications.
• Collaborate with Process Facilitators and Engineers on inspection floor initiatives.
• Apply strong problem-solving and prioritization skills to make independent decisions and provide guidance to team members on daily production activities.
• Support deviation investigations, CAPA execution, and SOP revisions as the inspection floor SME.
• Attend and actively participate in daily Tier 1 meetings.

Education & Experience

Minimum Requirements:

• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including demonstrated expertise across all inspection types and equipment and prior experience leading floor execution.
• Significant experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment, including knowledge of cGMP requirements, inspection processes, documentation practices, and investigation support.
• Mastery of visual defect detection and inspection accuracy across all material types handled on the floor.
• Strong organizational, analytical, and problem-solving skills with the ability to independently prioritize operations.
• Ability to effectively read, write, speak, and understand English to communicate technical information cross-functionally.
• Experience providing on-the-job training or technical guidance to peers while fostering a culture of compliance and continuous improvement.
• Ability to work effectively as part of a team in a fast-paced production environment.

Preferred Background:

• High school graduate, vocational school graduate, or equivalent.
• 4+ years of experience in a pharmaceutical, biotechnology, or cGMP-regulated manufacturing environment.
• Prior inspection experience.
• Experience in metrics tracking and reporting.
• Experience contributing to inspection process improvements, deviation investigations, and qualification programs.
• Experience working in a lean manufacturing environment.
• Working knowledge of Microsoft applications, SAP and/or Veeva Vault.

Physical & Work Environment

• This role is primarily a non-Sedentary role. This can include climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 pounds of force to move objects.
• Visual acuity such as working with data & figures, viewing computer terminal, extensive reading, operating machinery, operating motor vehicles, general observations of facilities, etc.
• Participation in an occupational health program, which can include medical assessment, surveillance, vaccination, and testing.
• Use of personal protective equipment, which can include respirators, Personal Air Purifying Respirators [PAPR], gowns, gloves, face protection, other barrier equipment, etc.
• All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
• Ability to pass eye exam during onboarding.

Work Schedule

12-Hour Days - 2/2/3 Schedule

The work schedule listed reflects the employee's expected schedule at the time of hire. The Company reserves the right to modify work schedules at any time, including a request to work overtime, with or without notice, based on business needs, operational requirements, or other considerations. Nothing in this description creates a guarantee of specific hours, days, or shift assignments

Sponsorship or support for work authorization, including visas, is not available for this position.

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, paid vacation, 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.