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.
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).
Relevant pharmaceutical experience
Understanding of programming, and proficiency in at least one language
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.
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.