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Manager, Automation Compliance

4 months ago

Kalamazoo, Michigan, United States Pfizer Full time


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 Process Automation team, you will be responsible for automation regulatory compliance and data integrity initiatives for both Drug Products and Active Pharmaceutical Ingredient (API) control systems. Also, responsible for implementing and maintaining the compliance programs for Process Automation control systems. It is your dedication and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

  • Provide 24x7x365 support of our automation systems from a compliance aspect.
  • Improving the compliance footprint for the automation organization by implementing continuous improvement practices for the automation team to follow related to regulatory, corporate, and site policies and practices.
  • Performing/managing records retention tasks Managing automation department compliance methodologies, strategies, systems, and standards including Data Integrity, SOP periodic review, CAS reviews, and other documentation.
  • Preparation and representation for automation in regulatory and customer audits.
  • Collaborating with Process Automation/Central Function colleagues on verification strategy and documentation requirements related to automation changes.
  • Communicating and collaborating with operations and automation colleagues to manage and/or perform user account reviews.
  • Assisting with automation department compliance investigations.
  • Data Integrity Assessment review and approval
  • Participate in the Engineering Compliance Services team representing automation.
  • Review system support documentation to ensure compliance.
  • Clearly communicate progress and issues to peers and management
  • Assist with onboarding, training, and mentoring process for Process Automation/Central Function colleagues.
  • Monitor and trend issues to identify and develop preventative solutions.
  • Demonstrate good planning, organizing, time management and team participation skills.
  • Adhere to safe work practices.

Qualifications

Must-Have

  • Applicant must have a High School Diploma (or equivalent) and 10 years of relevant experience.
  • OR an Associate's degree with 8 years of experience.
  • OR Bachelor's degree with at least 5 years of experience.
  • OR a Master's degree with more than 3 years of experience
  • OR a Ph.D. with 0-2 years of experience.
  • 10+ years of demonstrated experience in Automation Engineering and/or Regulatory Compliance.
  • Proficiency in Excel, Word, PowerPoint, SharePoint, and Teams.
  • Good Organizational skills and can meet task deadlines.
  • Proven ability to work in team environment and contribute as a team member.
  • Good communication skills.

Nice-to-Have

  • Pharmaceutical industry experience.
  • The ideal candidate should have background in cGMP regulations.
  • Broad understanding of process controls equipment and software.

PHYSICAL/MENTAL REQUIREMENTS

Office and plant environment. Keyboarding, lifting, standing, bending, walking.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Some weekend and overtime, especially during shutdowns. Supporting 24/7 operation – on call coverage.
  • Adhere to safe work practices.
  • Some travel (including international) required. (Approx. 5% of time)

Work Location Assignment:On Premise

Other Job Details:

  • Last Date to Apply for Job: January 27, 2024
  • Eligible for Employee Referral Bonus

The annual base salary for this position ranges from $93,500.00 to $151, 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 ). 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.

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