API Manufacturing Technician CRD-Manufacturing

PfizerGroton, CT
$30 - $50Onsite

About The Position

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. Your contributions will be vital in ensuring that our clinical manufacturing processes are efficient, compliant, and innovative, ultimately helping to deliver life-saving medications to those who need them most. 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, 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 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 has a strong understanding of procedures, processing techniques, tools, materials and equipment. Your decision making and collaboration with 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 utilizing previously acquired knowledge and experience, acting as a technical resource to others and working with experienced colleagues 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.

Requirements

  • High School Diploma or GED
  • 4+ years of relative experience
  • Demonstrated experience in a cGMP manufacturing environment.
  • Ability to think critically and demonstrate troubleshooting and problem-solving skills
  • Strong workload planning skills, organization, attention to detail, and follow through
  • Demonstrated capability to work as an independent contributor within a matrix development team
  • Excellent written and verbal communication skills
  • 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
  • Strong computer skills in Microsoft Office required, e.g. Teams, MS Word, MS Excel
  • Operational knowledge of DeltaV Production Control Systems
  • 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
  • Must be physically capable of standing for prolonged periods
  • Must be amenable to wearing personal protective equipment, including breathing hood (supplied-Air Respirators)
  • Permanent work authorization in the United States.

Nice To Haves

  • Associate degree (Science or technical discipline)
  • Strong 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 performing large scale distillations / Filtrations / milling

Responsibilities

  • Adhere to cGMP and standard operating procedure requirements.
  • 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.
  • Identify opportunities for continuous improvements and enable implementation.
  • Maintain cross-functional communication with tech transfer team: Compliance, Quality, Process Chemists, Analysists, and Process Supervisors.
  • Perform troubleshooting of manufacturing support equipment and operations.
  • Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
  • Generate, assist, and execute documentation associated with cGMP API manufacture, such as working batch record and cleaning documentation, and in-process control sampling.
  • Support equipment validation / commissioning activities.
  • 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, professional development, and be accountable for own results.
  • Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
  • 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.

Benefits

  • Eligibility for overtime, weekend, holiday and other pay premiums
  • 401(k) plan with Pfizer Matching Contributions
  • Additional Pfizer Retirement Savings Contribution
  • Paid vacation, holiday and personal days
  • Paid caregiver/parental and medical leave
  • Health benefits to include medical, prescription drug, dental and vision coverage.
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