About the role
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer’s mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.
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. This includes, but is not limited to: supporting the manufacturing operations team, reviewing Standard Operating Procedures, executing batch records, and supporting commissioning and qualification of process equipment. Standard work will involve chemical synthesis of API, which includes: solid / liquid charges, atmospheric / vacuum distillations, filtrations, liquid-liquid extractions, isolations, drying, purification 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 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
- With moderate supervision, execute Process Operating Instructions in a cGMP {part of GxP} environment.
- Responsible for equipment preparation, and cleaning of complex pharmaceutical manufacturing equipment as defined in standard operating procedures and with direction of experienced team members.
- Support equipment validation / commissioning activities.
- Adhere to cGMP and standard operating procedure requirements.
- Identify opportunities for continuous improvements and support implementation.
- Maintain cross-functional communication with tech transfer team: 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 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.
- 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.
Qualifications
Must-Have:
- Applicant must have High School Diploma or GED
- 2+ years of relative experience
- Demonstrated experience in a manufacturing or laboratory environment
- Familiarity with Production Control Systems
- Strong organization skills, and attention to detail
- Demonstrated capability to support others within a matrix development team
- Excellent written and verbal communication skills
- Strong computer skills in Microsoft Office required, e.g. MS Word, MS Excel
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
Physical/Mental Requirements:
- Ability to perform basic mathematical calculations (volume determination, density conversions, gross / tare / net calculations)
- Ability to learn and drive forklift
- Must be able to lift up to 50 lbs
Non-Standard Work Schedule, Travel, or Environment Requirements:
- Rotating 1st and 2nd shift schedule with some overnight and weekend coverage
Other Job Details:
- Last day to Apply: October 25th, 2024
- Eligible for Relocation Assistance: No
- Work Location Assignment: On Premise
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