Technical Associate CRD Manufacturing

Use Your Power for Purpose

Our breakthroughs would not reach the hands of patients without our dedicated pharmaceutical manufacturing team. We rely on agile members who understand the critical impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have timely access to the medicines they need.

What You Will Achieve

You will be part of a multi-disciplinary team responsible for the Current Good Manufacturing Practices (cGMP) production of non-commercial size clinical batches supporting the Pfizer Active Pharmaceutical Ingredient (API) small molecule portfolio development. This includes, but is not limited to: supporting the manufacturing operations team, following Standard Operating Procedures, executing batch records, and supporting colleagues on performing any activities involving process equipment or operational needs.

Standard work will involve chemical synthesis of API, which includes these operational tasks: solid / liquid charges to vessels, atmospheric / vacuum distillations, liquid-liquid extractions, phase split, crystallization, filtrations and drying, and milling.

As part of technical operations, you will be a team member who develops a good understanding of procedures, techniques, tools, materials and equipment. Experienced colleagues will help you prioritize workflows based on the available resources. You will follow standard operating procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team's success by working with experienced team members to support API manufacturing operations.

It is your hard work and focus that will help make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

* Adhere to cGMP and standard operating procedure requirements.

* With moderate supervision, execute Process Operating Instructions in a cGMP {part of GxP} environment.

* Responsible for equipment preparation, operational adjustment, process monitoring, sampling, and equipment cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures and direction of experienced team members.

* Identify opportunities for continuous improvements and support implementation.

* Maintain cross-functional communication with tech transfer team:
Compliance, Quality, Process Chemists, Analysists, and Process Supervisors.

* Assist experienced colleagues with troubleshooting of manufacturing support equipment and operations.

* Generate, assist, and execute documentation associated with cGMP API manufacture, such as working batch record and cleaning documentation, and in-process control sampling.

* Support Standard Operating Procedure Periodic Reviews.

* Report any deviations or observations that might lead to adverse impact on product quality or process safety.

* Actively participate in shift exchange activities and communication channels.

* Complete training to take part in safety inspections within the facility.

* Manage own time and professional development, be accountable for own results and begin to prioritize own workflow.

* Handle and segregate manufacturing waste in accordance with approved waste management, environmental, and safety requirements.

* Perform manual handling tasks, including lifting, carrying and moving objects weighing up to and exceeding 50 pounds on a routine basis throughout the work shift, using proper material‑handling techniques and safety practices.

Qualifications

Must-Have

* High School Diploma or GED with 2+ years of relevant experience

* Demonstrated experience in a manufacturing or laboratory environment

* Strong organization skills, and attention to detail

* Demonstrated capability to support others within a matrix development team

* Ability to think critically and demonstrate troubleshooting and problem-solving skills

* Ability to perform basic mathematical calculations (volume determination, density conversions, gross / tare / net calculations)

* Candidate must be physically capable of standing for prolonged periods, able to lift up to or in excess of 50 lbs, be amenable to wearing personal protective equipment and working with hazardous materials

* Excellent written and verbal communication skills

* Operational knowledge of computerized systems:
Proficiency in Microsoft Office Suite;
Familiarity with Delta

V Production Control Systems

Nice-to-Have

* Associate degree (Science or technical discipline)

* Mechanical aptitude and desire to execute hands on manual labor

* Experience with Delta V Production Control System

* Experience in a Pharmaceutical cGMP manufacturing environment

* Experience in commissioning and qualifying process equipment

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

PHYSICAL/MENTAL REQUIREMENTS

* Ability to perform basic mathematical…