The Technical Operations I colleague will primarily be responsible for the cleaning and sanitization of the Liquid Dose Manufacturing (LDM) suite, Andover Clinical Manufacturing Facility (ACMF) and the Cell Banking Suite (CBS). This position will be performing and learning basic techniques, processes and operations. The work is performed in strict compliance with manufacturing standards and all regulatory requirements. They will be responsible for completing all OJT's and tasks required to perform job duties which include documentation, computers, equipment, work practices within aseptic areas. The incumbent with demonstrate the ability to properly problem solve work-related issues, work with an appropriate level of independence, exercise good judgment/decision making, and effectively work with team members
- Sanitization of the Liquid Dose Manufacturing (LDM) Suite, Cell Banking Suite, and Andover Clinical Manufacturing Facility (ACMF)
- Maintaining LDM facility and ACMF equipment in clean, validated working order to be available for the manufacture of drug product according to cGMPs.
- Supporting/performing support operations in the manufacture of clinical drug product according to approved batch records.
- Responsible for supporting the operation of complex pieces of drug product manufacturing equipment.
- Generating SCADA reports, maintaining logbooks and other documentation as assigned.
- Communicating with peers, supervisors, and interdepartmental groups to provide for an efficient drug production process.
- Remain current on all training requirements and for completing all required procedural and skills training (ILT, OJT, etc.) prior to executing assigned tasks.
- Ensure a safe work environment, and attend training and health/safety courses per job requirements.
- Responsible for visual inspection of drug product vials
- Maintaining qualification for use of Personal Air Purifying Respirator
- High School Diploma or GED Required with 0-2 years of experience working in a GMP environment
- Must have experience following and executing approved SOP's in a regulated environment
- Work must be performed in strict compliance with manufacturing standards and all regulatory requirements.
- Associate's or Bachelor's Degree in Biology, Chemistry or Life Science concentration.
- 0-2 years of experience working in a regulated environment on a 3rd shift
- Must be able to pass sterile gown qualification.
- Job tasks may include frequent bending, lifting of up to 50lbs, and twisting motions.
- Ability to stand upright for several consecutive hours.
- Must be able to pass medical clearance for use of Personal Air Purified Respirator.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENTAL REQUIREMENTS
- Normal operations to be performed during third shift (11pm – 7:30am) some overtime work may be required.
- Most work performed in a Grade A and C controlled environment under cGMP regulations.
Other Job Details:
- Eligible for Employee Referral Bonus: Yes
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.
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.