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Sr. Automation Compliance Engineer

Employer
Pfizer
Location
Rochester, Michigan
Start date
Sep 22, 2022
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Job Details

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

The Sr Automation Compliance Engineer will have overall responsibility for managing regulatory aspects of the process automation and control systems used in the manufacture of sterile injectable. This position will provide engineering and technical support related to the operation, maintenance, installation,startup/commissioning,testing, and qualification of systems within a sterile injectable manufacturing facility.

How You Will Achieve It

  • Support the operation and troubleshooting of manufacturing equipment and control systems

  • Support reliability engineering for production and support equipment

  • Provide on the floor operational support as needed

  • Support all investigations and audits as needed

  • Provide off-shift and on call support when necessary

  • Responsible for Periodic review of the Automation Systems

  • Responsible for assuring various user levels have appropriate, documented training and authorization for access to engineering managed computer systems

  • Responsibility for managing regulatory aspects of the sites networked engineering data collection, monitoring and SCADA systems

  • Responsible for implementation of compliance initiatives including monitoring of system security procedures and practices, review of audit trails and system logins for compliance

  • Design and implementation support for minor functional and process changes, either smaller projects, remediation activities or capital projects

  • Support future capital projects and assure site automation standards are followed

  • Assist other departments in evaluating historical process/equipment data

  • Provide automation guidance and training to other functional groups (ie. Operations, Validation, Maintenance, etc)

  • Author and/or review design documents for projects and process changes

  • SupportFAT/commissioning/qualificationactivities as required

  • Responsible forbackup/archiving/restoringof Automation configuration and batch

  • Develop and implement site automation standards for hardware and software

  • Develop automation Standard Operating Procedures

  • System Admin for all site SCADA systems, Data Historians, and Engineering Site–wide Software Applications

  • System Administration for adding and disabling user access to Site Automation system

  • Maintain Manufacturing level network, control level networks and Process I/O network.

Qualifications

Must-Have

  • Applicant must a High School Diploma (or Equivalent) and eight years of relevant experience; OR an Associate's degree with six years of experience; OR a Bachelor’s degree with at least three years of experience; OR a Master’s degree with more than one year of experience.

  • Demonstrated experience in Automation Engineering

  • Experience with writing software test plans, user requirements, and system design documents

  • Experience on Automation Compliance projects

  • Familiar with process controls equipment

  • Strong knowledge of Computerized Systems, Compliance regulations and standards

  • Teamwork spirit, good communication skills and training abilities

  • Excellent interpersonal effectiveness and communication skills (written and oral).

Nice-to-Have

  • Relevant pharmaceutical experience

  • Understanding of programming, and proficiency in at least one language

PHYSICAL/MENTAL REQUIREMENTS

  • This is an on-site role at a penicillin manufacturing facility. Candidates must not be allergic to penicillin.

  • Lifting, sitting, standing, walking, bending, ability to perform mathematical calculations and complex data analysis, problem solving.

  • Ability to work in a gown room conditions.

  • Ability to write general correspondence and technical reports.

  • Requires good written, oral communication and presentation skills.

  • Requires good planning, organizing, time management and team participation skills.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Regular Work Schedule:

  • Standard (M-F) daytime. Overtime work may be required. Work requires on-site presence. Occasionalnational/internationaltravel for equipment factory acceptance testing, training seminars, vendor meetings, work progress meetings, etc.

Non-Regular Work Schedule:

  • At different times of the year, this position will work long hours for scheduled manufacturing shutdown periods and throughout the year may be required to work late with little notice as need arises when equipment is unexpectedly down.

  • Demonstrate proficiency in cGMP, GAMP, software development life cycle, environmental, health and safety procedures to assure compliance with regulatory, policies and/or established guidelines.

  • Observe and notify any risk situation for the environment, health or safety. Assure that all automation engineering initiatives comply with all regulatory agency requirements.


Other Job Details

  • Last Date to Apply: October 21, 2022
  • Eligible for Relocation Package: YES

Relocation assistance may be available based on business needs and/or eligibility.

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.

Engineering

#LI-PFE

Company

Join world-class scientists and leaders who are dedicated to bringing therapies that will significantly improve patients' lives.

As one of the world's premier innovative biopharmaceutical companies, we're driven to discover the cure --driven to significantly improve the lives of everyone...everywhere. If you're similarly driven, you'll find there's no better place to begin --and continue --your career than at Pfizer.

Science is the foundation of our company.  This is why it's no surprise that the most driven scientists in the world choose to carry out their life's passion at Pfizer.  We arm them with the resources, technology, and facilities they need to solve some of the world’s most complex health challenges. This combination empowers our scientists with expertise in vaccines, small-molecule medicines, biotherapeutics amongst many others, to collaborate on breakthrough science, including the world's first mRNA-Based Covid19 vaccine.  Our colleagues advance science and technologies into the therapies that matter most.

Join us and you'll partner with colleagues of diverse backgrounds and abilities who contribute to all aspects of what we do. Great things happen when people come together with one shared goal. If you're driven to discover the cure- ensure it has the latest technology to make it a reality or help improve the lives of others- join those who are similarly driven at Pfizer. The future of medicine is happening here.

Visit www.pfizer.com and connect with us.

 

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Find Us
Website
Phone
(212) 733-2323
Location
235 East 42nd Street
New York, NY 10017
United States
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