Job Information
Pfizer Manager, Engineering Verification, Strategy and Compliance in Sanford, North Carolina
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 Verification of GMP systems to meet quality standards with a focus on compliance. Your engineering verification skills will help in recommending and implementing improvements, modifications or additions that will help in solving problems. You will review system requirements against industry standards and implement these requirements to help Pfizer complete capital projects on schedule and within budget. You will also manage the system life cycle documentation for several of Pfizer's multi-product, process control systems in the manufacturing of vaccines and Gene Therapy components.
As a manager, your planning skills will help in preparing forecasts for resource requirements and providing verification execution schedules to complete project turnover. Through your comprehensive knowledge of the verification process, you will also be managing multiple contract groups on multiple capital projects. You will be able to take a cross functional leadership role to facilitate agreements between different team.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Estimate and manage capital project verification resources for automation and equipment to approved project schedules.
Participate, generate and/or review/approve standard operating procedures, job aids, risk assessments, commissioning activities, FATs and other capital project documentation.
Execute and manage multiple projects at the same time.
Apply good communication skills to keep customers, peers, and area management up to date with progress of all projects.
Comply with site SOPs, change control actions, commitments, CAPAs and other GMP requirements to deliver a verified GMP system to end users.
Support routine periodic review activities and re-qualifications, as needed.
Support regulatory audits, as requested.
Provide expertise for troubleshooting and resolution of issues related to verification and compliance
Assess potential impact of changes to qualified/verified systems (automation and equipment)
Scheduling and estimating verification resources required for capital projects.
Experience with writing test plans, user requirements, and system lifecycle documents
Direct knowledge and experience in capital project commissioning and verification within a biopharmaceutical or pharmaceutical cGMP environment
Experience using Documentum systems (such as PDOCS), learning management systems (such as PLS, P2L, PCEC), asset management systems (such as EAMS), document management systems (such as EDMS), commitment tracking systems (such as QTS)
Knowledge of FDA and/or GMP policies and procedures is required.
Develops and identifies continuous improvement opportunities and participates in cross-functional projects in support of plant objectives and goals with an emphasis on lean methodology and consistent with lean principles.
Qualifications
Must-Have
High School Diploma (or Equivalent) and 10+ years of relevant experience OR an associate's degree with 8+ years of experience OR a bachelor's with at least 5+ years of experience OR Master's Degree with 3+ years of experience, OR a PhD with 0+ years of experience.
Experience in computer, equipment, utility, cleaning or process Verification/Qualification/Validation within the pharmaceutical industry.
Thorough knowledge of cGMP (current Good Manufacturing Practices) and industry standards.
Strong history of problem-solving skills, project and task management skills, ability to manage priorities and lead others under pressure
Strong verbal and written presentation communication skills and attention to detail
Nice-to-Have
Computer systems verification of DeltaV, PI, BMS, and other process control systems.
Equipment verification of Autoclaves, CTUs, Fermentors, Sterilization, compressed gases, utilities, etc.
Experience with data integrity, audit trail evaluations, alarm management and the verification process.
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 day to apply: December 3rd, 2024
Employee referral bonus eligible
Relocation Support available
Work Location Assignment: On Premise
The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% 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
#LI-PFE