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Automation Project Lead

ROLE SUMMARY
The Automation Project Lead is responsible to manage and properly execute assigned automation projects supporting process, equipment and infrastructure for the McPherson Kansas Site.
This key role will directly provide process automation support in fill & finish, freeze drying process, inspection, packaging and support services design for manufacture of sterile injectable. Provide direct input into key decisions within the design for a future facility expansion from the perspective of automation strategy, and how this relates to how the facility and process equipment will be designed, commissioned, operated and supported.
With proven ability to accomplish projects independently, contributes in systems/automation engineering design for projects at the McPherson Site. Provide significant contributions on project teams and leads small project teams. Demonstrate the ability to successfully plan engineering projects and sustain high quality engineering contributions.
Provide guidance and training to junior staff. Develop and apply theories, methods and research techniques to the investigation and solution of technical problems. Supports the vision for the automation engineering function and acts as a change agent for technical innovation; performs risk-reward analysis and scenario planning.
ROLE RESPONSIBILITIES
Act as the primary point of contact with A/E design firm automation engineers
Provide client engineering input to scope definition for automation strategy for manufacturing equipment design along with associated support systems and infrastructure.
Act as a primary point of contact for automation design coordination with the engineering team.
Review and approval of concept engineering design deliverables
Review and approval of equipment package bid analyses
Provide engineering input into overall facility layout and design
Support input to the development of detailed capital project execution schedule
Provide engineering input into cost estimate preparation for the project.
Provide support to manage design quality and design change.
Provide technical support to partners within Engineering and Operations for automated systems.
Any other activities as directed by the Automation Manager.
QUALIFICATIONS
Education:
Bachelor's degree in Engineering required. (Chemical, Computer, Mechanical or Electrical).
Experience:
BS and 5+ years
Experience on Control System and Process Automation (Maintenance and/or Projects) including but not limited to PLC's, HMI's, DCS, Historians, Industrial Data Networks, Instrumentation and related hardware.
Knowledge of GMP, OSHA, FDA, MHRA and environmental regulations applicable to the pharmaceutical Industry.
Experience on supervising contractors including but not limited to project engineers, software developers.
Demonstrated track record of increasing professional responsibilities.
Hands on experience with process controls equipment including PLCs, DCSs, HMIs, SCADA systems, real-time data historians, batch execution systems, SQL relational database systems, and network infrastructure including design and debugging skills. Hands on experience with Windows Servers hardware and Microsoft Windows applications.
Hands on experience with communication protocols including but not limited to RS-485, RS-232, Ethernet, and Data Highway Plus, Control Net, Modbus, and instrumentation field busses (Device Net, Foundation Field bus, Profibus, etc).
Hands on experience in pharmaceutical environment including regulatory requirements associated with 21 CFR Part 11, EU Annex 11 and supporting validation of control system equipment.
Experience with writing software test plans, user requirements, and system design documents.
Strong organization, interpersonal, oral and written communication skills.
Prioritizing multiple commitments and technical problem solving ability.
Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.
Hands on experience in project management of capital projects.
Leads the site automation master plan
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
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.
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.
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.
Eligible for Relocation Assistance
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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