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 evaluati