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Specialist II, Manufacturing Validation



west chester, oh, usa
Posted on Friday, November 17, 2023

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

Position Summary & Responsibilities

Performs tasks in support of the pharmaceutical manufacturing processes and support systems. Provides validation support to the Process Execution Team (PET). Maintain the master site Validation Schedule to ensure continued compliance and Validation unique critical equipment/ supplies. Maintain the validation labs and calibrated equipment for continued use.

  • Review documentation needed for qualification of equipment and processes.
  • Coordinate validation activities with representatives from PETs. Supplement the PET staff during execution to ensure proper equipment placement (probes/ Bis and so on.)
  • Coordinate with PETs to manage validation documentation, scheduling and equipment availability.
  • Track Validation Change Controls.
  • Maintain equipment and systems along with their certification records.
  • Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on.
  • Coordinate qualification activities.
  • Work as a self-motivated individual in a team environment communicating effectively with all levels internal and external to the PET.
  • Create, edit, and review SOP’s for the Validation area.
  • Assist with troubleshooting and process improvement activities.
  • Read technical publications and manuals.
  • Maintain calibration of Validation equipment and support cleaning validation activities through prep and facilitation for operator qualification.

Minimum Qualifications

  • Experience in a GMP regulated production environment
  • Experience in writing and executing validation protocols
  • Ability to manage multiple activities with challenging timelines
  • Ability to be self-directed within a minimal time frame
  • Excellent written and verbal communication skills
  • Strong computer skills

Preferred Qualifications

  • High school graduate, Associates or BS in a technical discipline
  • Working knowledge of Microsoft applications, SAP, and Trackwise
  • Experience working in a LEAN manufacturing environment
  • Knowledge of cGMPs and FDA policies/ procedures

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.