Contamination Control Manager

Use Your Power for Purpose

The function of the Manger of Contamination Control is to oversee the activities performed by Aseptic Process Engineers. The manager will be responsible for ensuring that the facility layouts are in alignment with industry expectations and activities are occurring in areas with appropriate classification and ensuring newly designed area and activities are appropriately occurring per regulatory requirements and expectations. The leader will also be responsible for ensuring that Aseptic and Terminal Sterilization manufacturing areas are in compliance with proper aseptic and contamination control practices to support sterile manufacturing. In addition the manager will be responsible for the contamination control strategy for the site ensure that the current and new processes are aligned with regulations and industry best practices. The role holder will also communicate/partner with the global compliance experts/advisors and other Pfizer locations to ensure alignment to develop best in class operation and will be responsible for working with colleagues and other stakeholders to develop maintain and improve necessary strategies work plans risk assessments and schedules for the following:

Media fill strategy and

Smoke studies strategy and

Aseptic manipulation/process Compliance with regulatory requirements

Continuous improvement of the aseptic manufacturing area procedures and practices

Training on all setup and intervention procedures for colleagues and ensuring compliance against industry guidelines regulations and site procedures.

What You Will Achieve

In this role you will:

• Perform necessary assessments of sterile operations and work with the Operations teams to ensure proper process development control implementation and compliance with PQSs regulations and industry standards.
• Work with site colleagues to develop maintain and improve proper aseptic interactions/techniques to ensure the product/equipment is not compromised during qualification and/or subsequent commercial manufacturing
• Work alongside Operations Maintenance Validation and Manufacturing Quality to deliver key milestones for projects/improvements.
• Work with aseptic training team to develop necessary training for colleagues working in the aseptic manufacturing areas.
• Work with department leaders to ensure manufacturing procedures improvements and training materials are adequate for the job functions.
• Maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.
• Liaise with corporate compliance team other EC functions and other site departments to ensure alignment.
• Responsible for the implementation of aseptic practices in new aseptic areas to ensure alignment with industry expectations and current site procedures/practices.

Here Is What You Need (Minimum Requirements)

• Requires Bachelors Degree in a technical field such as Engineering biology etc with 5 year experience in a pharmaceutical manufacturing environment; Associates with 8 years of relevant technical experience or 10 years relevant technical experience
• At least 1 year of supervisory experience in a pharmaceutical environment
• Must have demonstrated experience in Aseptic Processing and contamination control understanding for sterile manufacturing
• Must have comprehensive knowledge of media fills and aseptic processing
• Requires thorough knowledge of GMP and understanding the application in aseptic processing
• Working knowledge of FDA regulations and regulatory requirements
• Knowledge of various quality tools specifically around investigations and trouble shooting
• Prior investigation writing experience (with determination of product impact)
• Excellent facilitation skills and ability to facilitate strategy meetings
• Superior technical writing and problemsolving skills
• Organize data extract key information and write technical summary reports

Bonus Points If You Have (Preferred Requirements):

• Masters degree is highly desirable coupled with relevant pharmaceutical experience
• Strong analytical and problemsolving skills
• Ability to lead projects by achieving objectives and preparing resource requirement forecasts
• Experience in taking risks to propel new concepts and methodologies forward
• Technical guidance and oversight capabilities to aid team members in problemsolving
• Strong collaboration skills to work effectively with crossfunctional teams and stakeholders

PHYSICAL/MENTAL REQUIREMENTS

May require sitting or standing for long periods of time.

NONSTANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Overtime and offshift hours may be required to support business needs.

Work Location Assignment:On Premise

The annual base salary for this position ranges from $to $. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 150 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 lifes 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). 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.

Engineering