Manager, Engineering Verification

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

Working with Pfizer's dynamic engineering team, you will play a critical role in automation development and testing on projects and day-to-day operations both remotely and in the field. Your Automation Validation skills will provide Commissioning, Qualification and Verification (CQV) support for all cGMP automated systems at the Sanford site related to the manufacture of biological drug substances and drug substance intermediates.

The position leads and/or participates in the planning, preparation and execution of validations for cGMP automated systems such as DeltaV, Unicorn, PLCs and other stand-alone systems. This includes generation and execution of test protocols, performing routine periodic reviews, maintaining life cycle documentation, revising standard operating procedures (SOPs), troubleshooting problems related to GxP operations, identifying and addressing Data Integrity and Audit Trail concerns, accessing the impact of change to qualified systems and interacting with regulatory authorities during audits.

At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to oversee and lead projects to ensure that cGMP automated systems perform as intended.

In addition, knowledge of electronic systems including PDOCs, LIMS, SAP, MS Word and MS Excel are required.

How You Will Achieve It

• Generation of qualification/verification protocols
• Execution of qualification/verification protocols remotely or in the field
• Completion of Final Reports for qualification/verification protocols
• Supervision and direction of others performing this work
• Perform routine periodic review activities
• Provide/maintain Site Validation Master Plan information
• Support regulatory audits through the preparation, defense and interaction with auditors in areas related to automation systems
• Provide expertise for trouble-shooting and resolution of issues related to automated systems
• Assess potential impact of changes to qualified/verified automated systems
• Generate and revise standard operating procedures and job aids.
• Identify and implement CQV best practices to continuously improve the site validation program
• Represent automation validation on site or network teams as necessary
• The position requires execution and management of multiple projects at the same time and good communication skills to keep customers, peers, and area management up-to-date with progress of all projects in order to ensure validations are completed in a timely manner and on schedule.

Must Have

• A minimum of a BS degree + 7 years of experience; MS + 4 years of experience in any of the following disciplines: Biochemistry, Biotechnology, Chemistry, Chemical Engineering, Mechanical Engineering, Electrical Engineering, or equivalent science related or engineering discipline.
• 4+ years of demonstrated experience in Automation Engineering or Validation in a GMP Manufacturing environment.
• Experience with test plans, user requirements, and system lifecycle documents.
• Comfortable working in a manufacturing environment.
• Relevant pharmaceutical experience.
• Familiar with process control systems and equipment.
• Familiar with Computerized Systems, Compliance regulations and standards.
• Teamwork spirit, good communication skills and training abilities.

• DeltaV and/or PLC experience.
• Understanding of programming, and proficiency in at least one language.
• Direct knowledge and experience in automation qualification or verification within a biopharmaceutical or pharmaceutical cGMP environment is desired.
• Experience with FDA and EU licensing and inspection is preferred.
• Experience with project management is preferred.
• Additional experience in other areas of validation, particularly verification, is a plus.
• Experience using Documentum systems (such as PDOCS), learning management systems (such as Plateau, PLS, Sum Total, P2L, PCEC), asset management systems (such as EAMS), document management systems (such as EDM), commitment tracking systems (such as QTS)

US/PR colleagues who are issued an Incident Final Warning (IFW) disciplinary action are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

US/PR colleagues who are on an active Performance Improvement Plan (PIP) are not eligible to post and compete for a position for the duration of the Performance Improvement Plan (PIP).

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.

PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an office-based work environment with some shop floor exposure. There are no unusual physical or mental requirements for this position.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Schedule is primarily on 1st shift (8am to 5pm) but may require off-shift work on occasions.

The position will require working on the floor in manufacturing areas at times which will require a focus on safety. Aseptic gowning could be 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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