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
We are seeking a motivated individual for the role of Technical Associate (SDM Operations Group T2) in our Solid Dose Manufacturing (SDM) facility in Groton, CT. The focus in the SDM will be on batch-process manufacturing for tablet and capsule formulations. The successful candidate will provide day to day manufacturing support meeting timelines, schedules, and operational quality standards in alignment with current GMP guidelines for manufacturing activities for clinical drug product supplies. Primary responsibility includes performing daily activities which include cleaning, equipment set-up and pharmaceutical manufacturing processing for oral solid dosage forms with a focus on compliance and continuous improvement. The successful candidate must demonstrate strong teamwork dynamics when interfacing with various groups (e.g., Operations, Quality, Tech Support, GWS).
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.How You Will Achieve It
- Manufacture solid dosage forms (tablets and capsules) for developmental, stability and clinical studies/supplies.
- Set-up, operate, clean, and maintain complex pharmaceutical manufacturing equipment associated with Solid Dose processing using closed transfer systems.
- Implement cGMP procedures and safe handling techniques for solid dosage processing.
- Generate, assist and execute documentation associated with solid dosage manufacture such as, working batch record documentation, Logbooks, labels and in-process run sheets
- Proficient and use of digital tools (electronic logs, forms and batch records)
- Generate, assist and execute equipment lifecycle documentation such as; Qualification Protocols, Periodic Reviews, and Change Control documentation.
- Create and revise Standard Operating Procedures (SOP) for cGMP manufacturing equipment and activities.
- Assist with Quality Compliance reviews and investigations focused on root causal factors as well as identifying Corrective and Preventative actions.
- Complete activities identified as operator care tasks associated with the maintenance and operation of complex novel pharmaceutical manufacturing equipment.
- Complete activities associated with the operation and maintenance of the SDM cGMP manufacturing space.
- Sound understanding of computational mathematic tools and formulas (i.e. ability to calculate yield, batch accountability, operational ranges, coating efficiency and percentages).
- Identify, own and lead continuous improvement-based projects using Lean Manufacturing Techniques
- High School Diploma or GED
- 2+ years of experience
- Demonstrated experience in a biotechnology manufacturing or laboratory environment
- Operational knowledge of computerized systems
- Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems
- Maintains a safe work environment
- Demonstrated capability to work as a team member in a matrix development team
- Excellent oral and written communication skills
- Strong computer skills in Microsoft Office required, especially MS Word, MS Excel
- Bachelor's Degree
- Knowledge of fermentation and or downstream processing techniques
- Mechanical aptitude and desire to execute hands on manual labor
- Standing, walking, bending, climbing, reaching, and lifting upward of 55 pounds may be required.
- Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Role requires a Groton site presence. Off-shift and weekend work may be required.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.Manufacturing