Specialist II, Manufacturing, Process Coordinator 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

The Specialist II performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include assisting with manufacturing investigations; issuance, revision, and authoring of documents; maintaining team production metrics for shift. The position provides oversight, execution, and approval for transactions in SAP and Veeva as well as ensuring that OEE performance data is collected as specified for each operating area.

Job Responsibilities

• Maintain an advanced knowledge of the SAP system and execute SAP transactions as required to complete process orders.
• Technical writing to include investigations, line assessments, and corrective actions.
• Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable.
• Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
• Investigate manufacturing deviations; close out deviations, CAPAs and/or AFCAs as needed.
• Review completed production documentation (for example: batch records, log books, and so on) for quality, completeness, and cGMP compliance.
• Author/Approve/Review/Revise/Audit SOPs, Work Instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
• Coordinate cross-functionally with other departments as required.
• Attend team meetings to discuss progress, initiatives, and/or other matters.
• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on.
• Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
• Complete required training.
• Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation.

Education, Qualifications, Skills, and Experience

Minimum Requirements

• Experience in documentation in a cGMP environment
• Experience in a pharmaceutical or cGMP regulated environment.
• Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
• Good attention to detail is required. Individual must be capable of keeping accurate records and performing mathematical calculations.

Preferred Background

• Experience in a production environment
• High school graduate, vocational school graduate or equivalent, Bachelor’s degree or equivalent
• 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.