Andover-LDM Process Engineer
What You Will Achieve
Working with Pfizer’s dynamic engineering team, you will play a critical role in developing and modifying process formulations, methods, and controls to meet quality standards. Your production engineering skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review product requirements in terms of product development compatibility and help Pfizer determine optimum costs and schedules of production.
As a Process Engineer, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.
The Andover Liquid Dose Manufacturing (AN-LDM) Process Engineer within the Pharmaceutical Research and Development (PhRD) organization supports the Clinical Manufacturing (CM) Group.
The position will report to the Director of PhRD Clinical Manufacturing Technology Group (CMTG) in Andover MA.
The successful applicant will join the AN-LDM team and provide process engineering support for delivering new technologies to the Clinical Manufacturing group; support the definition of specifications and design requirements of equipment/technologies per current GMP/BPE standards for the PhRD unit.
The applicant will provide process/production engineering subject matter expertise (SME) across a variety of unit operations, possess a process design and validation background and production related troubleshooting skills, demonstrate basic project management skills for small to medium size projects to support the full lifecycle of pharmaceutical assets.
The applicant will provide engineering technical support related to the maintenance, installation, startup/commissioning, testing, and qualification of process equipment, process related systems, and infrastructure equipment within a variety of PhRD facilities.
The applicant shall provide detailed engineering on change controls and functionality upgrades to existing systems.
The process engineer will interact with key stakeholders across all areas of the facilities, interpreting the asset requirements to bring them together with the aim of ensuring high asset performance as defined by the following:
EAMS (CMMS) for all PM/CM activities by trended analysis
Collaboration with Quality Unit for all change management and compliance related activities to meet minimum Quality System requirements.
PM support and maintenance support
Interaction with Service Contractors for key critical assets for LDM
Operator Care understanding
Problem Solving/Decision Making:
Troubleshooting problems as they arise on an asset – finding efficient and effective solutions with engineering.
Ensuring that ALCOA (Attributable to the person generating the data, Legible and permanent, Contemporaneous, Original record (or true copy) and Accurate) principles of data integrity are met in all asset activities
Skilled at the use of Enterprise systems like QTS (Quality Tracking System), EAMS (Enterprise Asset Management System)
Applying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs
Makes decisions that may require developing new options to resolve moderately complex problems.
Makes decisions guided by policies in non-standard situations.
Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results. Requires relevant scientific education, skills, and knowledge.
Collaborate to innovate and develop ideas with all relevant organizations that support the manufacture of Drug Product including but not limited to Quality, Validation, Operations, and Compliance.
How You Will Achieve It
Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for short-term work activities on own projects.
Work closely with technical services to develop and confirm Critical and Key Process Parameters needed for Equipment and Process Validation.
Report team progress, highlight risks, clarify issues, suggest recommendations, and present next stage development plans.
Coordinate, schedule & participate in daily activities of (Current) Good Manufacturing Practices (part of GxP) production in the manufacturing area to meet supply chain needs.
Facilitate effective project meetings with internal team members and with customers.
Ensure that the process adjustments are incorporated into the appropriate final version of SOPs, and Master Batch Records
Provide trouble-shooting and technical support to Pfizer manufacturing groups as required.
Responsible for participating in the execution of process and cleaning validations as well as related activities and projects including continued process verification.
Adhere to site safety standards, participate in routine safety training events, and enforce safety and biosafety requirements as they relate to the PhRD.
The Process Engineer will reside primarily on-site focused on the following key responsibilities:
Supporting in-suite process activities for AN-LDM production in a clean room environment, ISO class 5 (Grade A)
Design asset changes & Maintenance of all LDM assets in EAMS
Work with senior engineers and user-base for all asset upgrades
Ensures the assets remains on schedule & compliant.
Contribute to weekly POR (Plan of record) sustainable asset performance for All Drug Product Fills
Contribute to ongoing reporting of the asset status.
In addition to Drug Product assets the job requirements may involve support of process related equipment for cell culture, harvest, or purification related assets.
Bachelor's degree in chemical, mechanical, bio-medical engineering, or relevant discipline with 2 years of experience
Knowledge of Good Manufacturing Practices and experience in pharmaceutical environment
Knowledge of theory and principles within a professional discipline or advanced knowledge of specific technical/operational practices
Strong technical, management and organizational skills
Good leadership and communication skills
Relevant Computer skills (Microsoft products such as Teams, PowerPoint, and Excel)
Ability to work across functional areas such as operations, maintenance, and validation are required to provide appropriate support.
Candidate is required to have experience with Data Integrity and 21CFR Part 11 ERES requirements.
Collaborative skills and effective partnering skills in complex working environments.
Ability to work in a dynamic multi-discipline organizational model.
Ability to focus on an open concept work environment.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Minimal travel required.
Other Job Details
Work Location Assignment: On Premise.
On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
Last day to Apply: October 4th, 2023
Relocation assistance may be available based on business needs and/or eligibility.
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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.