Specialist II, Manufacturing - Process Coordinator; BLU), Dayshift

Job Description

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

Brief

Job Description:

Specialist II, Manufacturing, 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 EDMS/QMS system (Veeva) as well as ensuring that OEE performance data is collected as specified for each operating area.

• Maintain an advanced knowledge of the SAP system and execute SAP transactions as required to complete process orders.
• Daily and weekly coordination of activities to ensure production schedule is met.
• 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.
• Communicate policies and procedures to employees.
• Establish visual tracking and other tools to enhance audit readiness and trend analysis.
• Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
• Lead training on all document modifications prior to effective date.
• Initiate appropriate action when process deviations occur via Veeva. Report process deviations when they occur.
• 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 manufacturing of commercial product.
• Coordinate cross-functionally with other departments as required.
• Alert others (e.g., Supervisor/Manager) when problems occur outside of SOPs.
• Attend team meetings to discuss progress, initiatives, and/or other matters.
• Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs, including general safety, lock outs, and so on.
• Wear PPE (Personal Protective Equipment) as required by specific activities.
• Complete required training.
• Complete duty‑based packets by reading SOPs and excerpts from technical documentation.
• Gather, organize, and communicate operational information to others.
• Lead process improvement activities and teams to meet strategic goals.
• Create training modules and/or resources to ensure that SOPs are covered.
• Monitor key performance indicators to meet strategic goals.
• Monitor training of employees to ensure compliance.
• Perform quality audits and walk‑throughs to check calibration tags, eye wash station, anything labelled, floors, and so on.
• Attend inter‑departmental meetings to discuss matters involving the coordination of multiple departments.
• Read technical publications and manuals and write associated procedures.

• 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.

• 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 offers employees a robust total rewards program including an annual cash bonus program, a 401(k) plan with a generous company match, and benefits package thoughtfully designed to support…