Technical Associate, Clinical Manufacturing, Production Support (2nd Shift)

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

The clinical manufacturing Production Support Technical Associate is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.

The successful candidate will be a part of a team responsible for the execution of media & buffer formulation, Clean Out of Place (COP), Parts washer & autoclave operations, and weighing and dispensing of raw materials to support Production Support operations.

• Support execution of solution formulation and Weigh/Dispense operations in a GMP environment

• Support equipment set up, CIP, SIP, Clean Out of Place (COP)/Offline Parts Washing and Autoclave operations

• Support troubleshooting of production support equipment and operations

• Performs routine standardization and functional checks for process instrumentation for daily use in production

• Completes work instructions and maintains clean room environment to comply with regulatory requirements

• Supports material handling activities, including picking of materials to GMP manufacturing facility and finished product from production to interim storage (cold and frozen storage).

• Works on routine assignments per written procedures and batch records with guidance from senior associates.

• Adheres to good manufacturing practices, standard operating procedures and good documentation practices

• Maintains a safe work environment.

• Completes GMP forms and/or batch records as required

• Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.).

• Reviews work throughout the process and at completion, in order to ensure that it has been performed properly.

• Supports planning/organization of work to ensure that activities are performed effectively, and to respond to fluctuating workloads.

• Cross-functional communication with technology transfer teams, lab scientists, supply chain, quality and engineering as necessary

• Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Advises Shift supervisor on improvements which may optimize work processes.

Must-Have

• High School Diploma or GED

• Requires a minimum 0-3 years of experience in a biotechnology manufacturing or laboratory environment.

• Operational knowledge of computerized 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

• Mechanical aptitude and desire to execute hands on manual labor

Nice-to-Have

• Bachelor's Degree, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent

• Knowledge of Media/ Buffer solution preparation, Glass wash, Autoclave, fermentation and or downstream processing techniques

• Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site

• Ability to work off shift (Weekends) as needed; non-routine

• Familiarity with Production Control Systems, Enterprise Resource Planning Systems and other business systems

Other Job Details:

• Position includes sign on bonus

• Work Location Assignment:On Premise

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to climb flights of stairs, and be standing for ~1-2 hours at a time.

• Must be able to lift up to 50lb

• Ability to work in a clean room environment

• Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to work off shift (Weekends) as needed; non-routine

• Ability to work overtime

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

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 Act

Pfizer 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 Eligibility

Pfizer 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.