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

This role will have overall responsibility for managing regulatory aspects of the process automation systems and infrastructure used in the manufacture of sterile injectable at the Pfizer McPherson, KS site.  The successful candidate will assist with compliance, infrastructure, cybersecurity, and network tasks. 

This may include server and active directory configuration, switch and network design, network access point maintenance and configuration, general network troubleshooting, UPS maintenance, virtual machine and virtual cluster maintenance and configuration, user account reviews, data integrity assessments, system data tracking, and system license management.  In addition, there is a strong project management focus for project tracking data and team metrics.

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

• Support FAT/commissioning/qualification activities as required

• Responsible for backup/archiving/restoring of 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 have a High School Diploma (or Equivalent) and 8 years of relevant experience; OR an Associate degree with 6 years of experience; OR a Bachelor's with at least 3 years of experience; OR Master's with more than 1 year of experience.

• Background in cGMP regulations, be up to date on cybersecurity methodologies and the practical application of those methodologies to control systems.

• Familiar with process controls equipment including PLCs, DCSs, HMIs, SCADA systems, SQL relational database systems, virtual machine environment and network infrastructure including design and testing skills.

• Integrated manufacturing systems

• 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}

• English proficiency

• Computer Literate

PHYSICAL/MENTAL REQUIREMENTS

• 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

• Supporting 24/7 operation.

Regular Work Schedule:

• Standard (M-F) daytime.  Overtime work may be required.  Work requires on-site presence. Occasional national/international travel 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

• Relocation Support Available

• Work Location Assignment: On Premise

• Last Day to Apply: April 10, 2023

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