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Technical Operations 3, Clinical Manufacturing


Andover, MA
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Job Details

Job Title Technical Operations 3, Clinical Manufacturing

JobID 1609351

Location: Andover, MA

Description Job Description

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.

**Key Responsibilities**

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

**Basic Qualifications**

+ 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

**Behavioral Competencies**

+ Adaptability to changing work assignments and priorities

+ Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model

+ Excellent teamwork

+ 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**

+ **Grade: 006**

+ Eligible for Employee Referral Bonus

+ Location: Andover, MA

**EEO Statement**

**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.

**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.

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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