Lead Engineering Technical Services
Pfizer
Cajamarca, Cajamarca, PE
hace 2 días
source : WHATJOBS

Role Responsibilities : Support design, selection and maintenance of pharma sterile injectable equipment and allied clean and black utilities.

Act as a single point of contact with Pfizer Global Engineering ensuring consistency of equipment, technology application across the network.

  • The role will also be pivotal in sharing equipment successes across the network Lead equipment and facility fit assessments for new products into the Vizag Site Custodian of process descriptions from an equipment perspective Custodian of equipment URSs, Equipment drawings, P&IDs;
  • specifications and equipment qualification packages Member of the Engineering Leadership Team Strong collaboration across functional lines to ensure robust manufacture of products and project implementation as well as rapid resolution of technical issues Technical leadership & regular communication to stakeholders in relation to resolution of technical challenges (internal & external to Engineering) Own programs to drive technology excellence culture at site Ensure effective allocation of Equipment / Validation / Process Engineering resources to deliver Operating Unit required projects and equipment improvements Support development of site wide standard approaches for equipment validation Responsible for ensuring the equipment & systems run to target efficiencies, and all applicable Key Performance Indicators (KPIs) targets are met.

    Work closely with Plant Eng lead from this perspective Provide technical support to plant engineering, instrumentation, automation, calibration, facility management and utility leads and their teams Lead the investigations for the equipment and systems within scope of the position Ensuring compliance to cGMP and Safety requirements mandated by site and Pfizer corporate standards Support development of the Site Master Plan and Site Space Plan to ensure optimum use of technology Design reviews, co-ordination with external agencies & internal customers for the design and specification of new equipment.

    Help capital project teams to during design, equipment selection, testing, CQV phases Leverage and reinforce utilization of HR tools and resources Basic Qualifications : Bachelors degree in Engineering (Mechanical / Chemical / Electrical / Instrumentation) 15-20 years of experience in fill finish (injectables) pharmaceutical industry.

    Firsthand experience as Technology lead 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 Preferred Qualifications : Advanced education (Masters or PhD) is preferred Technology exposure by working with multinational Pharma organization This is a people manager role Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Engineering #LI-PFE

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