Process Engineer II, Technical Compliance

## Process Engineer II, Technical Compliance申请locations:
United States
- Massachusetts
- And overtime type:
全职posted on:
今天发布job requisition :
4959285
** Why Patients Need You
** 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.
** What You Will Achieve
** As a member of the Technical Compliance Support team, you will work cross-functionally to implement changes within Operations, ensure compliance of the manufacturing suites, support audits / inspections, support risk assessments, and CAL OOTs.
You will coordinate and perform compliance walkthroughs of the manufacturing areas. You will support and own low risk change controls as well as participating in other change controls by performing impact assessments ensuring that the change will not negatively impact operations.

You will own multiple projects at a time and will be responsible for delivering to the milestones on time.  You will also be responsible for owning activities such as CAPAs, change actions, revising SOPs.  The Technical Compliance Support team supports all the manufacturing suites in Andover which will enable you to work with multiple teams within and outside Operations Support.
** How You Will Achieve It
*** Contribute to completion of project milestones and organize own work to meet project task deadlines.
* Drive own projects to completion.
* Use operational and technical expertise to assist in implementing changes in manufacturing.
* Support urgent Planned Temporary Changes to ensure Operations is set up for Right First-Time manufacturing.
* Ensure all production areas are in a state of compliance and audit ready at all times.
* Coordinate and perform monthly compliance walkthroughs and ensure follow up actions are completed.
* Support audits and inspections by serving as a functional area lead in the backroom.
* Support audit response drafting and finalization.
* Initiate and close CAL OOTs.
* Participate in or perform risk assessments based on business need.
* Drive continuous improvement in the work processes associated with support of commercial manufacturing and change management.
* Support activities and projects that are in scope of the Technical Compliance Support team.
** Here Is What You Need** (Minimum Requirements):
* BA/BS degree with any years of experience, or Associate's degree with 4+ years of experience, or high school diploma (or equivalent) with 6+ years of relevant experience.
* Knowledge of process equipment and manufacturing operations.
* Ability to follow standard operating procedures and regulatory guidelines.
* Basic understanding of Current Good Manufacturing Practices.
* Strong organizational skills to manage project tasks and meet deadlines.
* Technical documentation skills for production and process approvals.
** Bonus Points If You Have** (Preferred Requirements):
* Experience with in the pharmaceutical industry
* Experience with writing Change Controls
* Experience in deviations as responsible person
* Familiarity with programs such as Veeva Vault, EAMS, PDOCs
* Experience with Six Sigma or other operational excellence programs
** Physical/Mental Requirements
*** Daily routine may require standing for long periods of time and/or walking throughout the suite including up and down stairs.
* Must be able to don cleanroom gowns.
* The incumbent needs to take the necessary safety precautions when working within the manufacturing suites.
* The incumbent must be able to express ideas into SOPs, assessments, and be able to use a multitude of programs including Excel, Word, Power Point, etc.
** Non-Standard Work Schedule, Travel or Environment Requirements
** This is a first shift, Monday to Friday role; however, this group supports the manufacturing suites which operate outside those hours. Occasionally, support will be required outside of the normal first…