Job Description

ROLE SUMMARY

summarize the primary purpose & key accountabilities of the role. Summary should be concise and include strategic information that would attract candidates to the role. It may be helpful to complete this section after you have finished the other sections of the document.

• Responsible for Project Management of Utilities at the site.
• Coordinate with vendors/consultants/CFT & for Commissioning, installation, Qualification & handover of Equipment to user.
• Responsible for Project Management/ execution of assigned projects (short duration), which includes the management of internal company resources (assets financial and personnel), external Engineering and vendors as part of the execution of projects. The direct management responsibility includes all support activities and functions necessary to ensure successful completion of project objectives
• Preparation, review & Approval of Qualification Documents (URS, DQ, FAT, SAT, IQ, OQ & PQ).
• Review & approval of vendor documents/technical documents/drawings and provide inputs to in line with site requirements & Perform Gap analysis of utilities requirement and implement the actions
• Support development of a world-class sterile injectables manufacturing site at Vizag by providing equipment Engineering and Technology expertise.

ROLE RESPONSIBILITIES

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 key result areas that highlight accountability and level of judgment required.

Key Areas

Activities

Project /Finance Management

• Preparation, review & Approval of Qualification Documents (URS, DQ, FAT, SAT, IQ, OQ & PQ).
• Initiating, planning, executing, monitoring, controlling, and closing all the assigned projects at Site.
• Coordinate with vendors/consultants/CFT for smooth execution of projects
• Support projects & engineering function in identifying, mapping and driving projects of Utilities at site to enable engineering as well as site goals and objective delivery.
• Central point of contact for Utilities for smooth execution of projects.
• Prepare a detailed project plan using appropriate project tracking tools and work with project team assigning cost and time schedule to each project in line with the project approval.
• Devise implementation plan & evolve with contingency plan and interact with the team for risk identification, plan for mitigation and implementation throughout the project lifecycle.
• Review & approval of vendor documents/technical documents/drawings and provide inputs to in line with site requirements
• Gap analysis of utilities requirement and implement the actions
• Responsible for Commissioning, installation, Qualification & handover of Equipment to user
• Ensure all equipment installed is safe, effective and in compliance with industry standards
• Own the equipment drawings, P&ID\xe2\x80\x99s, and act as the primary link into the Automation team for the assigned equipment sets
• Support the design and selection of process & ancillary equipment.
• Own the relationship with key vendors for the Utilities through this relationship speed up troubleshooting and faultfinding responsiveness, improve equipment and spares availability through the equipment lifecycle
• Responsible to Coordinate with Global Functions, Equipment engineering SME\xe2\x80\x99s, Process Engineering SME\xe2\x80\x99s, Automation SME\xe2\x80\x99s.
• Financial Accountability to support generation of site capital budget by proposing appropriate technology solutions
• Involve in prioritizing the projects related to utilities
• Accountable for obtaining the expected results of the programs under his/ her responsibility.
• Conduct regular review meetings to monitor/update projects progress with respect to scope, schedule, and cost.
• Engage functional stakeholders, identify, delegate and track action items for resolution. Update project plans & deliverables as required.
• Develop and maintain the knowledge databank of technical and functional outputs of the projects.
• Able to leverage on available knowledge in the network for success of projects.
• Participate in site reviews and Governance process engaging key stakeholders, sponsors and facilitate decision making to deliver performance to the expectation
• Support assessing training requirement of the Maintenance and operators and develop, in collaboration with the OEMs as required, appropriate and tailored training plan. Provide technical training on process and equipment in collaboration with OEMs, as required
• Support the design and selection of process & ancillary equipment.

Documentation/Compliance

• Ensure all company and site engineering policies and procedures are adhered to.
• Review and approve documentation for cGMP validation, requalification and periodic review of systems, equipment & manufacturing processes, including validation plans, risk assessments, protocols, and reports to maintain the equipment in a validated state
• Review all documents in relation to all improvements and upgrades

Cultural Attributes

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

Statutory Obligations

• Provide technical expertise during audits and to present/ defend engineering systems, applicable change controls, investigations and equipment requalification packages to the regulatory agencies if required.
• 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 that all safety instructions and measures are strictly observed.
• Conducting Safety Assessments

ESSENTIAL REQUIREMENTS

Determines the education, experience and competencies that a person needs to have in order to do the job effectively

Preferred Education/ Qualification (Eg. Diploma, Certificates, bachelor\xe2\x80\x99s degree, Master\xe2\x80\x99s Degree, licenses, technical certification)

• Bachelor\xe2\x80\x99s degree in Engineering (Mechanical / Chemical / Electrical / Instrumentation)

Experience (type and length of experience needed to perform effectively)

• 5-15 years of experience in utilities of pharmaceutical industry

Core Competencies (refers to skills, knowledge and attributes that an employee must possess to be competent in the position

Detailed knowledge of the following:

• Knowledge and understanding of the US cGMP (21 CFR Parts 210, 211)
• Understanding of the local safety and environmental regulations
• Understanding of electronic batch records and electronic signatures (21CFR Part 11)
• Ability to communicate with site & corporate global functions
• Well versed with industry best practices and guidelines such as those with ISPE, PDA, ASME, etc.

Standards, Processes & Policies

• Basic HSE and GMP/QA knowledge
• Knowledge on Clean room requirements, behavior, Good documentation work and Regulatory Guidelines

DESIRABLE REQUIREMENTS

Identify the \xe2\x80\x98nice to haves\xe2\x80\x99. These are not critical but would be advantageous.

Advanced Competencies (Up to 5 advanced competencies can be list)

• Documentation Preparation and review skills
• Effective problem-solving capabilities
• Excellent Interpersonal, written and communication skills
• Effective coordination between departments

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