Sr. Specialist, QC Systems at Resilience

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:

Resilience seeks a Sr. Specialist, QC Systems, to support the LIMS system for the East Norriton facility. The successful candidate will support daily use and maintenance of the LIMS system in addition to system configuration updates, process enhancements and corresponding validation and change activities.

The Sr. Specialist, QC Systems, will partner and collaborate with Manufacturing, QA, QC and MSAT operations to ensure all LIMS related business needs are met. This individual will also partner closely with digital global colleagues, administrators, and external stakeholders to ensure streamlined and efficient operations of LIMS activities, meeting partner needs and complying with standard operating procedures.

The position will be in our East Norriton, PA facility.

Position Responsibilities:

• Development and configuration of test method attributes within LIMS inclusive of but not limited to final result parameter lists, consumables, equipment, and data tables

• Translation of test methods into the Laboratory Execution System module of LIMS

• Collaboration with Analytical Development and Quality Control colleagues to ensure proper method configuration within LIMS

• Generation and execution of validation (user acceptance testing) of LIMS test methods

• Configuration, revision and validation testing of LIMS sample plans

• Configuration of stability studies in LIMS

• Establishment and/or revision of LIMS related processes

• Daily support and training for LIMS end-users

• Other activities as assigned.

• Will require occasional early morning, late evening, and/or weekend work.

Minimum Qualifications:

• Experience with operating in a LIMS environment and system configurations

• Basic understanding of computer system validation

• Basic understanding of cGMP requirements

• Several years of relevant experience within a GMP environment

Preferred Qualifications:

• Demonstrated knowledge / thorough understanding of LES/ELN modules of a LIMS environment, preferably LabVantage LIMS

• Experience in building test methods and/or processes within LIMS

• Strong planning and organizational skills

• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across multiple sites and stakeholders

• Excellent attention to detail

Other Ideal Personal Characteristics:

• Proven record of cross-functional and matrix team leadership

• Excellent interpersonal, verbal and written communication skills

• Experience in application of lean methodologies and operational excellence principles

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 $85,000.00 - $115,000.00 per year. 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.