Engineering Validation Manager

Employer
Pfizer
Location
Sanford, North Carolina
Posted
Jun 21, 2022
Ref
4857694
Required Education
Bachelors Degree
Position Type
Full time

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

ROLE SUMMARY

This role has accountability for some or all of the following:

  • Verification, qualification and/or validation of cGMP systems

  • subject matter expertise for facilities, equipment and controls

  • project management

  • engineering input in problem solving

  • continuous improvement activities

  • engineering change management

  • engineering regulatory compliance

ROLE RESPONSIBILITIES

  • Provides site leadership and support for the qualification, verification and validation of equipment, facilities and controls as well as ownership of key engineering systems in compliance with internal guidance & external regulations.

  • Provides leadership, supervision and performance management to the Engineering Validation department. Establishes department goals, objectives and performance expectations for direct reports and the department. Provide priorities, ongoing feedback and recognition.

  • Responsible for personnel activities of the department such as recruitment, hiring, performance evaluations, succession planning and salary adjustments. Monitors department personnel progress in accomplishing assigned project objectives, quality, budget and scheduled commitments. Provides counseling to colleagues as needed and assures that appropriate training is provided to department colleagues. Enforces company and departmental policies and procedures.

  • Establishes contacts across the Pfizer network and externally within the industry to share best practices for qualification, verification and validation processes and standards.

  • Adheres to and enforces all site safety standards. Participates in safety training events and ensures that all staff safety training is completed in a timely manner.

  • Ensures the department adheres to cGMP requirements and is fully trained in all relevant policies and procedures as well as all federal and global regulations.

  • Provides feedback to peers and colleagues in other departments, and actively supports activities such as safety, continuous improvement and recognition.

Qualifications

Must-Have

  • A minimum of a BS in an engineering or scientific discipline with at least 7 years relevant experience (or MS +4 or PhD +2) in the biotech, pharmaceutical or biopharmaceutical industry.

  • Relevant experience in a biotech or biopharmaceutical manufacturing environment could be obtained in Engineering, Quality, Technical Operations, Manufacturing or Development.

  • At least 5 years of direct supervisory-level or managerial-level experience is required.

  • Incumbent should have strong administrative, managerial, computer, and presentation skills.

  • The incumbent should also have experience in pharmaceutical manufacturing, process equipment, project management, qualification, verification and validation.

  • A thorough understanding of the relevant portions of cGMP regulations is required. Experience in project management and/or qualification and verification is required.

  • The incumbent should demonstrate the highest technical and managerial competency and should demonstrate the capability to assume higher managerial posts.

  • In addition to scope of responsibility, other factors impacting level include technical complexity, budgetary accountability, level of interpersonal/outside contacts, and critical thinking/decision making ability.


PHYSICAL/MENTAL REQUIREMENTS

Position requirements are typical for an office-based work environment with routine excursions to job sites and utility or manufacturing areas. There are no unusual physical or mental requirements for this position.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The incumbent in this position would typically work a routine weekly work schedule but travel to other Pfizer sites, industry conferences and other events would be normal and expected. Night or weekend work may occasionally be required to meet project deadlines.

Other Job Details:

  • Last Date to Apply for Job: July 5th, 2022

  • ​Relocation Assistance Available

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.

Quality Assurance and Control

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