Manufacturing Technician IV, Lead - DAP (Night Shift)
Resilience · West Chester, OH · 1 mo ago
Management$26–$40.5/hrFull-time
Resilience is a technology‑focused biomanufacturing company changing the way medicine is made. The company builds a sustainable network of high‑tech, end‑to‑end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.
Responsibilities
- Operations lead and monitor complex process activities to ensure successful operations on the production floor.
- Perform technician tasks as required including start‑up, equipment operation, manual packaging, and line clearances.
- 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 a continuous‑improvement project resource.
- 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.
- Review process documents such as operational SOPs, forms, and batch records for accuracy.
- Maintain all required certifications and qualifications for the assigned work area.
- Serve as a technical resource for the team, providing subject‑matter support to production and mechanical technicians.
- Act as a certified OJT trainer on assigned equipment and process tasks, training and supporting team members.
- Collaborate with Management and Engineers on packaging floor initiatives.
- Apply strong problem‑solving and prioritization skills to make independent decisions and guide team members on daily operational activities.
- Attend and actively participate in daily Tier 0 meetings.
Minimum Qualifications
- Significant experience in a pharmaceutical, biotechnology, or cGMP‑regulated manufacturing environment.
- Advanced knowledge of cGMP requirements and quality systems, including deviations, change control, and data integrity.
- Demonstrated ability to work independently and resourcefully to resolve complex production issues and provide guidance to team members in a fast‑paced production environment.
- Proven ability to review and ensure accuracy of critical GMP documentation and batch records.
- Strong organizational, analytical, and problem‑solving skills; ability to make informed decisions under pressure.
- Applied quantitative skills sufficient to interpret production data, evaluate trends, and support investigations and continuous‑improvement work.
- Experience providing on‑the‑job training to peers in a manufacturing environment.
- Ability to effectively read, write, speak, and understand English to communicate technical information cross‑functionally.
- Ability to work effectively as part of a team in a fast‑paced production environment.
Preferred Qualifications
- High school graduate, vocational school graduate, or equivalent.
- 4+ years of experience in a pharmaceutical, biotechnology, or cGMP‑regulated manufacturing environment.
- Prior experience serving as a subject‑matter resource or trainer on the production floor.
- Experience in a lean manufacturing environment.
- Working knowledge of Microsoft applications, SAP and/or Veeva Vault.
Physical & Work Environment
- Non‑sedentary role involving climbing, kneeling, repetitive motion, temperature changes, and exerting up to 100 lb of force.
- Visual acuity required for data review, computer terminal work, extensive reading, and operating machinery.
- Participation in an occupational health program (medical assessment, surveillance, vaccination, testing).
- Use of personal protective equipment such as respirators, PAPR, gowns, gloves, face protection, and other barrier equipment.
- Must be able to pass an eye exam during onboarding.
Pay
Target base pay hiring range: $26.00 – $40.50 per hour. Actual base pay depends on factors such as geographical location, relevant experience, qualifications, skills and knowledge.
Benefits
- Annual cash bonus program.
- 401(k) plan with generous company match.
- Comprehensive healthcare including medical, dental, and vision.
- Family‑building benefits.
- Life and disability insurance.
- Paid vacation, paid holidays, and other paid leaves of absence.
- Tuition reimbursement.
- Support for caregiving needs.
Schedule
Typical schedule reflects expected hours at time of hire (e.g., 8 hours Mon‑Fri, 10 hours Mon‑Thu, or 12 hour 2/2/3). The company may modify schedules, request overtime, or change shift assignments based on business needs.