Pfizer Sr Automation Engineer in McPherson, Kansas

ROLE SUMMARY

The Sr Automation Engineer - Pack, Serialization, VI 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 pack lines, serialization and visual inspection systems within a sterile injectable manufacturing facility.

ROLE RESPONSIBILITIES

  • 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

Education :

  • Bachelor's degree in Engineering required (Chemical, Computer, Mechanical or Electrical).

Experience:

  • Five years of experience in process automation with integrated manufacturing systems and ancillary equipment, preferably in a pharmaceutical or relevant GMP manufacturing environment.

  • Understanding of SOP's, Change Control and all related GMP Pharmaceutical systems.

  • Excellent communication and interpersonal skills.

  • Hands on experience with Systech Vision System / TIPS, OPTEL Vision System / Serialization - LineMaster, PharmaProof, OSM Server.

  • Familiarity with industrial communication networks.

  • 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 Statement

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.

  • Last Date to Apply: May 28, 2018

  • RELOCATION WILL BE PROVIDED

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.