Senior Technical Writer

Role Summary

Pfizer is seeking a highly motivated and experienced candidate to support GMP non-testing activities for the validation group at the Andover site. This candidate is responsible for writing, procedures, Requirement Specifications, investigations/deviations, commitments and change controls. This position requires working collaboratively with the QC raw materials, QC Analytical, QC Micro, Quality Assurance and Manufacturing.

This candidate will manage change control action items and ensure on time closure of change controls. This candidate will actively participate in scheduling, visual management, metrics, and continuous improvement activities. The successful candidate will be team oriented, have a passion for excellence, act with integrity, demonstrate equity and inclusivity, seek continuous improvement opportunities, actively participate in site recognition programs, and take pride in his or her contribution to the team.
 

Role Responsibilities

• This position will provide support for the validation program and validation projects at the Pfizer Andover site.

• Writing and reviewing technical documents such as instrument validation requirement specifications, protocols, standard operating procedures, investigations, deviations, commitments and change controls.

• Provide technical support and fully implement change controls and commitments.

• Execute test protocols associated with change controls and commitments.

• Support internal and external audits.

• Apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

• Plan and prioritize projects and track completion rates for projects.

• Demonstrated leadership skills in decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines.

• Proficiency with computer systems (Trackwise, Veeva Vault, PDOCS, LIMS, etc.).

• Strong oral and written communication skills

• Candidate must be self-motivated and be able to adapt to rapidly changing project priorities and prioritize projects appropriately.

• Experience also required: background in problem solving, negotiations, and project management/support in a matrixed reporting environment. Candidate must be willing to work with vendors, QC, Manufacturing, Validation teams and have excellent customer service skills.

• Knowledge and experience in cGMP USP/EP/JP, regulatory guidance and audits

• Experience with DMAIC, and continuous improvement tools desired

Qualifications

• Applicant must have a High School Diploma (or Equivalent) and 8 years of relevant experience OR an Associates degree with 6 years of experience OR a Bachelors with at least 3 years of experience OR Masters with more than 1 year of experience.

• Experience working in GMP environment in pharmaceutical industry

• Instrument Validation / Computer Systems validation Experience required.

• Knowledge and ample experience in authoring Change Control, investigation, Commitment and Deviations.

• Strong technical writing skills required.

PHYSICAL/MENTAL REQUIREMENTS

Normal lifting, sitting, standing, and walking requirements to facilitate required in a laboratory environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour (weekend) support may be required to support staff and operations.

Work Location Assignment: On Premise

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.

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