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'll help bring medicines to the world even faster by imagining what’s possible and taking action.

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.

ROLE SUMMARY

The Andover Liquid Dose Manufacturing (AN-LDM) Senior  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 in Andover MA.

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, and demonstrate project management skills for small 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 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 analysisCollaboration with Quality Unit for all change management and compliance related activities to meet minimum Quality System requirementsDetailed engineering on change controls and functionality upgrades to existing systems PM support and maintenance supportInteraction with Service Contractors & LDM Asset Lead for key critical assets for LDMOperator Care understanding

ROLE RESPONSIBILITIES

The Process Engineer will reside primarily on-site focused on the following key responsibilities:

Lead the execution of troubleshooting activities for multiple unit operations within the Clinical Manufacturing and PhRD facilities in direct support of offline and real time GMP production operationsExecute commissioning plans, validation/qualification documents, troubleshooting, executing the qualification activities, assisting maintenance, attending necessary meetings, and maintaining specific training requirementsDesign and implementation of ALCOA (Attributable to the person generating the data, Legible and permanent, Contemporaneous, Original record (or true copy) and Accurate) ensuring principles of data integrity are met in all process system designs 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.Job requirements require the ability to achieve and maintain access to Grade A area facility gowning and aseptic methodsJob requirements will involve fill finish, lyophilization, formulation equipment, production services equipment and labeling/inspection process equipment; development of user requirement specification (URS), functional requirement specification (FRS) and maintenance recommendations and proceduresSkilled at the use of Enterprise systems like QTS (Quality Tracking System), EAMS (Enterprise Asset Management System)Develops and manages plans to achieve objective; to include mentoring/coaching of junior engineersThe position will require equipment maintenance history review, investigation, and audit supportSupporting 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 EAMSCollaborates with engineers and user-base for all asset upgradesEnsures the assets remains on schedule & compliantContribute to weekly POR (Plan of record) sustainable asset performance for All Drug Product FillsContribute to ongoing reporting of the asset statusIn additionto Drug Product assets the job requirements may involve support of process related equipment for cell culture, harvest, or purification related assets

Problem Solving/Decision Making:

Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results. Requires relevant engineering/scientific education, skills, and knowledgeTroubleshooting problems as they arise on an asset – finding efficient and effective solutions with engineeringEnsuring 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 activitiesRequires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Unit/Sub Operating Unit meets its goalsApplying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPsMakes decisions that may require developing new options to resolve complex problemsMakes decisions guided by policies in non-standard situations

ROLE RESPONSIBILITIES

The Process Engineer will reside primarily on-site focused on the following key responsibilities:

Lead the execution of troubleshooting activities for multiple unit operations within the Clinical Manufacturing and PhRD facilities in direct support of offline and real time GMP production operationsExecute commissioning plans, validation/qualification documents, troubleshooting, executing the qualification activities, assisting maintenance, attending necessary meetings, and maintaining specific training requirementsDesign and implementation of ALCOA (Attributable to the person generating the data, Legible and permanent, Contemporaneous, Original record (or true copy) and Accurate) ensuring principles of data integrity are met in all process system designs 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.Job requirements require the ability to achieve and maintain access to Grade A area facility gowning and aseptic methodsJob requirements will involve fill finish, lyophilization, formulation equipment, production services equipment and labeling/inspection process equipment; development of user requirement specification (URS), functional requirement specification (FRS) and maintenance recommendations and proceduresSkilled at the use of Enterprise systems like QTS (Quality Tracking System), EAMS (Enterprise Asset Management System)Develops and manages plans to achieve objective; to include mentoring/coaching of junior engineersThe position will require equipment maintenance history review, investigation, and audit supportSupporting 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 EAMSCollaborates with engineers and user-base for all asset upgradesEnsures the assets remains on schedule & compliantContribute to weekly POR (Plan of record) sustainable asset performance for All Drug Product FillsContribute to ongoing reporting of the asset statusIn addition to Drug Product assets the job requirements may involve support of process related equipment for cell culture, harvest, or purification related assets

Problem Solving/Decision Making:

Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results. Requires relevant engineering/scientific education, skills, and knowledgeTroubleshooting problems as they arise on an asset – finding efficient and effective solutions with engineeringEnsuring 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 activitiesRequires exceptional knowledge of own discipline and advanced knowledge of others and applies these skills to ensure a Sub Business Unit/Sub Operating Unit meets its goalsApplying technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPsMakes decisions that may require developing new options to resolve complex problemsMakes decisions guided by policies in non-standard situations

Leadership:

Creates an environment where innovation is standard taking appropriate risks to advance innovative processesDevelops ideasand leads complex projects across Sub Business Unit/Sub Operating UnitDevelops innovative solutions to complex problems impacting a Sub Business Unit/Sub Operating UnitExercises own judgment and is a resource for others.  Works independently with assignments often self-initiated 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.

Qualifications

Candidate must have a BS or MS in chemical, mechanical engineering, or relevant disciplineCandidates must have a minimum of 7 years (6 years with MS) of experience in Process/Production engineering with pharmaceutical process systems executing design, commissioning, and troubleshooting activities

OR

Candidates with same or more experience in Innovative or Technology Industry with relevant preferred qualifications

AND

Candidate is required to have experience with Data Integrity and 21CFR Part 11 (GMP for finished Pharmaceuticals)Expertise to include systems and equipment within one or more of the following areas: biologics drug substance, biologics drug product and GMP utilities

PREFERRED QUALIFICATIONS

Relevant Computer skillsAseptic cGMP Drug Product Manufacturing experienceAbility to work across functional areas such as operations, maintenance, and validation are required to provide appropriate supportAbility to work self-directed, and exercise considerable latitude in determining objectives and approaches to assignments and provides guidance and manages work activities of others.Good communication skills, verbal and written, are requiredThey must have a working knowledge of cGMP type systems and practices

PHYSICAL/MENTAL REQUIREMENTS

Collaborative skills and effective partnering skills in complex working environments.Ability to work in a dynamic multi-discipline organizational model.Ability to focus in an open concept work environment

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Minimal travel required.
Work Location Assignment: On Premise

The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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.  This position requires permanent work authorization in the United States.

Engineering

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