Specialist II, Manufacturing (dayshift)

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

Brief Job Description

This position: 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. This is a dayshift position Monday-Friday, 8 hour days.

Job Responsibilities (Including Key Result Areas, Specific Accountabilities, Tasks, Etc.)

• 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. 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 (Good Manufacturing Practices) manufacturing of commercial product.
• Coordinate cross-functionally with other departments as required.
• Alert others (for example: Supervisor/Manager) when problems occur outside of SOPs (Standard Operating Procedures).
• 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.
• 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 (Standard Operating Procedures) 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.

Typical People Management Responsibility (Direct/Indirect Reports)

Approximate Number of People Managed in Total (All Levels): 0

☐ Matrix Manager (Projects/Dotted Line)

☐ Manager of a Team

☐ Grandfather (Manager of a Manager)

☒ N/A

What is the Global Remit (In How Many Countries Will the Role Operate)

☒ Own Country

☐ Another Country

☐ 2 or 3 Countries at a Minimum of 40% of Time

☐ 4 or More Countries at a Minimum of 40% of Time

Education, Qualifications, Skills, and Experience

Minimum Requirements

• Experience in documentation in a cGMP environment
• Experience in a pharmaceutical or cGMP regulated environment.