Operations Technician- MAP Mod 1

This posting is for one 1st shift MAP MOD 1 Operations Technician supporting the Filling and Freeze Dry team

The MAP Mod1Technician role is responsible for supporting the production of injectable drug products in the Modular Aseptic Processing (MAP) Mod 1 facility in the filling freeze dry and capping unit. Although Techs may specialize in one specific area (i.e. filling freeze dry capping) they will be required to cross train and perform work in other processing steps run in that area. Work is performed in strict compliance with manufacturing standards (SOPs) and following all regulatory requirements (i.e. GMPs & OSHA).

What You Will Achieve

Setting up and changing over the equipment per approved procedures

Performing unit operations in the production area with a variety of different equipment types.

Washing sanitizingand cleaning facilities and equipment

Handling and allocating component materials

Monitoring process parameters and batch end reportsfor quality or equipment concerns

Utilizingcomputer skills to interact with multiple complex PLC and SCADA systems

Collaboratingwith maintenance and engineers totroubleshootequipment and perform TPM tasks

Supportingdevelopment andexecution of capital projects corrective actions and continuous improvement ideas

Demonstratinggrowth mindset to share best practices & utilize downtime effectively

Workingsafely and compliantly following all applicable SOPs and standards including recording of GMP documentation

Achieving and maintaining appropriate certification to work within graded spaces

Completing and maintaining all required training on time

Demonstrating ownership and accountabilityof theproduction schedule and product quality

Executing in-process quality inspections

Developing and contributing to IMEx activities.

Other duties as assigned by the supervisor

Here Is What You Need (Minimum Requirements)

• High School Diploma or GED

• 6 years of experience

• Strong oral and written communication skills

• Proficiency in current Good Manufacturing Practices (cGMPs)

• Ability to draft and revise operational procedures

• Ability to troubleshoot and resolve technical issues

• Strong organizational skills and attention to detail

• Capability to work independently and as part of a team

• Proficiency in using standard office software and manufacturing systems

Bonus Points If You Have (Preferred Requirements)

• A Bachelors Degree

• Experience with Lean Manufacturing principles

• Knowledge of regulatory requirements and quality standards

• Familiarity with Pfizers Learning Solution and Quality Tracking System

• Ability to adapt to changing priorities and manage multiple tasks

• Ability to train and mentor less-experienced colleagues

• Familiarity and basic understanding of common AI tools and a curiosity for learning how they can be used to enhance productivity

PHYSICAL/MENTAL REQUIREMENTS

• lifting/lowering up to 55 pounds working in high elevations (above 6 feet) and reaching/standing/walking/stooping/crawling.

• Able to wear safety PPE (Hard hat body harness face shield)

Able to work under clean room (GRADE C/D) environments with appropriate gowning

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

This position is for 1st shift operations (7am-3:30pm) with ocassional evening and weekend overtime

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.