Pfizer Technical Operations 3, Clinical Manufacturing in Andover, Massachusetts
Technical Operations 3 of Biotherapeutics Drug Product Manufacturing is a GMP Drug Product manufacturing position responsible for the execution and review of batch records following site approved standard operating procedures (SOP) inside the Andover Liquid Dose Manufacturing Facility (AN-LDM). This position will maintain and prepare equipment, revise SOPs, Train personnel, formulate drug products, aseptically fill and inspect drug products manufactured in the AN-LDM according to approved SOPs and batch records.
Responsible for the equipment preparation, formulation and filling of biologic drug products in the AN-LDM Facility. Complete initial review of executed batch records, revise SOPs, train personnel and coordinate with third shift. Tech 3 will execute and leading formulation and filling processes, for preparing sterile medicines and formulation equipment. Work is performed in strict compliance with manufacturing standards and all regulatory requirements. Responsible for completing all OJT's (On the Job Training) and tasks required to perform job duties which include: documentation, computers, equipment, work practices within aseptic areas, and production of all defined routine products. Demonstrates ability to properly problem solve work-related issues, work with an appropriate level of independence, exercise good judgment/decision making, and effectively work and communicate with team members
Biotechnology Certificate or High School/GED
5-8 years' Experience in Aseptic filling operations
Experience in cGMP compliance as related to manufacture of biologics
Excellent oral and written communication skills; authoring of SOPs
Comfortable with training new operators
Role tasks will include frequent bending, lifting (up to 40 pounds) and twisting motions.
Ability to stand for several consecutive hours
Absence of any medical restrictions which could restrict completion of all required duties
Technical Skill Requirements
Must be able to meet gowning requirements
Ability to read, understand and follow written instructions
Master and lead formulation and filling operations
Current understanding of working under cGMP regulations
Pass eye exam for visual inspection of drug products
Ability to communicate with peers, supervisors, and interdepartmental support groups
Adaptability to changing work assignments and priorities
Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model
Interpersonal and communication skills
Able to identify opportunities for continuous improvements and enable implementation
Additional Offer Details
Last Date to Apply for Job: October 2, 2017
Eligible for Employee Referral Bonus
Location: Andover, MA
EEO & Employment Eligibility
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