Automation Lead

Pfizer Inc.

Vizag, India

Job posting number: #7135211 (Ref:pf-4879623)

Posted: March 21, 2023

Application Deadline: Open Until Filled

Job Description

ROLE SUMMARY:

  • Conceptualization, Design and Execution of Projects towards the journey of Industry 4.0
  • Connect and coordinate with Global SMEs for new introductions, implementation, and harmonization of contemporary new business technologies relevant to the industry.
  • Shall be accountable for operation and maintenance of DCS, C-LAN, Historian, and regular upgrades, and for ensuring backup and disaster recovery procedures and tools.

Shall be accountable for maintenance and troubleshooting of process equipment, electronic and instrumentation in facility and utilities, qualifying and maintaining PLC driven equipment, machines, and instruments, BMS/EMS/TMS, instrumentation in facility and utilities.

ROLE RESPONSIBILITIES:

Equipment Qualification:

  • Ensure adequate support in qualifying of equipment.
  • Review new concepts, communicate with vendors for new requirements and preparation and review of URS for new equipment.
  • Coordination of any additional activities with Cross functional teams on behalf of Engineering
  • Ensure all the Engineering equipment/ instruments / systems are qualified and maintained as per the schedule of calibration, preventive Maintenance & periodic re-qualification.
  • Review and approve qualification protocols.
  • Review and approval of engineering drawings and layouts

Equipment Maintenance:

  • Ensure equipment/instruments are maintained in good condition.
  • Coordinate with user to plan preventive maintenance, calibration, software backups and other activities periodically.
  • Support for modifications for improvement of the machine/ equipment performance.
  • Study & review operations, to contribute substantially for energy conversation & productivity improvements.
  • Ensure upkeep of plant & building w.r.t GMP standards & to carry out special tasks assigned from time to time.
  • Ensure the health check of maintenance & calibration programs adhering to CMMS program schedules.
  • Ensure the trending of failures / breakdowns and propose corrective actions.
  • Guiding the team during breakdowns, trouble shooting and rectifying the basic causes in shortest possible time.
  • Study & review standby facilities for critical sub-assemblies and addition of capital equipment on long term basis for smooth operation.

Project management:

  • Handling of new/expansion/improvement projects
  • To identify continuous improvement initiatives (process improvement, energy efficiency, etc.)
  • Ensure implementation of identified initiatives.

People Management:

  • Engage and inspire the team on performance expectations and coach the team to meet those expectations using coaching skill principles.
  • Focus on safety and GMP Compliance as operational priorities and as performance measures that should be included in metrics.
  • Know the processes and procedures, including the principles and practices of good data management (ALCOA), and be able to guide, advise and coach the team.
  • Be accountable for the good data management and data integrity understanding and performance of the team.
  • Effectively monitor the actions of the team. Ensure an active daily presence in the GMP work area to observe the work activity and practices.
  • Any compliance deviations noted must be investigated in accordance with Site standard operating procedures. Be available to the direct reports for real time escalations of any concerns or support needs.
  • Be observant, investigate and report actions or behaviors that may negatively impact the desired outcome of the GMP process or activity.
  • Lead and support continuous improvement efforts, where applicable.
  • Be a role model to support a positive compliance culture.
  • Review the content of all Leader Led Conversations and, on an annual basis, conduct two ‘Leader Led Conversations’ with the teams aimed at fostering a culture that supports compliance with procedures, including good data management.
  • Be vigilant for potential actions or behaviors that could result in breaches of GMP compliance or data integrity principles. 

Reporting:

  • Prepare departmental budget and control the expenses within approved/ sanctioned limits.
  • Review of equipment breakdown data
  • Review & prepare management information system (MIS) reports of the engineering.

Documentation/Compliance:

  • Review of incident investigation reports and supporting investigators in the identification of root cause of incidents
  • Develop procedures to comply with guidelines.
  • Review and approval of GMP / quality documents & procedures
  • Implement cGMP and ensure compliance with laid down SOPs, quality systems, safety systems at all stages of activity
  • Extending required support during walkthroughs, internal audits & regulatory audits
  • Ensure all relevant procedures like standard operating procedures & testing procedures and other procedures are in place and being followed.
  • Ensure all the team performing operation and maintenance of equipment / instrument are trained on relevant procedures.
  • Ensure the activities being carried out in the engineering are in line with the approved procedures.
  • Ensuring on time closure of change control and CAPA action items.

Staff Management

  • Reviewing performance of team members
  • Ensuring development of team through individual development plans (IDP)
  • Guiding and coaching the team

Cultural Attributes

  • Conduct himself/herself in line with the Pfizer values, Courage, Equity, Excellence & Joy

Statutory Obligations

  • Conduct himself/herself in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.

Environmental Health and Safety

  • Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety management system manual.
  • Ensure plant and personnel safety.
  • Ensuring that health and safety guidelines are strictly followed.

Core Competencies:

  • Knowledge of installation, operation, and maintenance of electronic and instrumentation systems in facility and utilities
  • Experience in implementing and standardization procedures and processes.
  • Expertise in electronic and instrumentation related activities in the facility and utilities
  • Knowledge of installation, operation, and maintenance of electronic and instrumentation in facility and utilities
  • Conversant with validation documents and protocols execution per schedule
  • Knowledge on maintaining backup and restore procedures and tools for automated equipment.
  • Detailed knowledge of preventive maintenance schedules / task lists, SOP’s, and various audit procedures
  • Knowledge on 21CFR part 11 compliance
  • Knowledge on regulatory requirements
  • Knowledge on computer system validation

Standards, Processes & Policies

  • cGMP and GDP in pharmaceutical Industry
  • Knowledge on clean room requirements and regulatory guidelines
  • Knowledge on metrological standards
  • Good, automated manufacturing practice guidelines for validation of automated systems.

Advanced Competencies:

Interpersonal skills: Effective communication with all staff from different levels and build constructive and effective relationships.

Written communication: Ability to write well-structured technical reports; excellent attention to details.

Process management: know how to organize people and activities to ensure efficient workflows and simplified processes.

Holds people accountable: clearly assigns responsibility for tasks and decisions, set clear objectives and measures, monitors process, progress, and results.

Conflict resolution skills: rapport and relationship development. Able to articulate persuasively to obtain superior performance from staff at all levels in the organization.

Additional Desirable Requirements:

Acts Decisively: Makes decisions in a timely manner, makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment; Effective project management skills and demonstrated ability to manage multiple competing priorities.

Grows others: Provides challenging and stretching tasks and assignments; Demonstrated leadership skills; ability to use initiative and drive to achieve results

Emotional Intelligence: Identify, assess, and control the emotions of oneself and awareness of others; Strong interpersonal skills; Must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately.

Qualifications 

Must-Have 

  • Graduate / Diploma engineer in electronics and instrumentation engineering/ Electrical and electronics engineering/ with specialization in instrumentation

  • Project management tools and techniques. 

  • Good people management skills. 

  • Strong PC skills and experience of packages such as CMMS, Purchasing Information System. 

  • Knowledge of manufacturing techniques and recognized tools. 

 

Nice-to-Have 

  • Master’s degree and relevant pharmaceutical experience. 

  • Strong Communication and Leadership skills. 

  • Training/certification and/or experience in the application of maintenance reliability principles, in particular, Reliability Centered Maintenance, Total Productive Maintenance (emphasis on operator care), work control systems to include CMMS and MRO Inventory Management. 

  • Training/certification and/or experience in Failure Modes and Effects Analysis, Equipment Life Cycle Costing, Root Cause Failure Analysis (using DMIAC principles) and Overall Equipment Effectiveness data retrieval, calculations and reporting. 

  • Ability to coach, counsel and lead a team of people. 

  • Ability to manage a wide variety of activities at the same time. 


Work Location Assignment: On Premise

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

Engineering



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.


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More Info

Job posting number:#7135211 (Ref:pf-4879623)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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