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AN-LDM Asset Lead Engineer

Employer
Pfizer
Location
Andover, Massachusetts
Start date
Sep 23, 2022

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Discipline
Administration, Finance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work
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Job Details

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what’s possible and taking action.

ROLE SUMMARY

The Andover Liquid Dosage Manufacturing (AN-LDM) Asset Lead 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 day-to-day review of CMMS (Computerized Maintenance Management System; Pfizer EAMS) for all identified Assets for LDM, Andover Pilot, and Andover Cell Banking.

The Asset Lead will own the maintenance & reliability of the Assets within EAMS. They will be responsible for asset activities including planning, forecast, scheduling, and some budget. The Asset Lead will provide maintenance engineering & reliability engineering management of identified assets through collaboration and careful planning with engineers within the CMTG and operational staff within CM group.

The asset engineer will interact with key stakeholders across all areas of the facilities, interpreting the needs, expectations, and limitations of each, and bring them together with the aim of successful asset performance as defined by the following:

  • EAMS (CMMS) Gateway for all PM/CM activities
  • Collaborate with PGS/EMU scheduling, planning personnel for maintenance activities
  • PM Optimization, BOM development, stockroom/spare parts inventory optimization
  • Lifecycle Roadmap & Total Cost of Ownership
  • Reliability Engineering, Bad Actor Evaluations, FMEAs, etc.
  • Service Contracts
  • Operator Care implementation
  • Capital Renewal/Forecasting with Engineering
  • Cost Control as defined with Engineering

ROLE RESPONSIBILITIES

The Asset Lead will reside primarily onsite at the project site focused on the following key responsibilities:

  • Maintenance & reliability of all assets in EAMS
  • Planning and forecasting of the asset
  • Keeping the asset on schedule/compliance
  • Keeping the asset on budget
  • Ongoing reporting of the asset status
  • In addition to Drug Product assets the job requirements may involve maintenance of cell culture, harvest, or purification process equipment

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 is 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
  • Able to operate independently in ambiguous situations

Leadership:

  • Liaising with contractors, suppliers, and internal company stakeholders to deliver asset performance
  • Ensuring that all aspects of the project proceed while adhering to internal company SOPs as well as external regulations and laws – this includes maintenance of asset documentation
  • 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.

BASIC QUALIFICATIONS

  • Candidate must have a BS or MS in chemical, mechanical, electrical engineering, or relevant discipline
  • Candidates must have a minimum of 6 years (5 years with MS) of experience with complex pharmaceutical process systems
  • OR
  • Candidates with same or more experience in Innovative or Technology Industry with relevant preferred qualifications

PREFERRED QUALIFICATIONS

  • 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
  • Good communication skills, verbal and written, are required
  • Working knowledge of cGMP type systems and practices
  • Candidate is required to have experience with Data Integrity and 21CFR Part 11 ERES requirements

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Minimal travel required.

Other Job Details
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.

Engineering

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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