Principal Manufacturing Systems Engineer

Quick Facts

• Role: Principal Manufacturing Systems Engineer

• Focus: IS/automation delivery for a technologically advanced drug substance manufacturing plant with Industry 4.0 capabilities

Description

Own the successful delivery of a varied portfolio of IS/Automation projects, including portfolio planning, resourcing, risk and financial management. Anticipate and resolve multiple simultaneous project issues, delays, and problems using technical, project management, and business expertise, while performing cross-system assessments, feasibility analysis, and scope projects to recommend optimal solutions. Elicit and analyze business customer needs and convert them into functional design, translating strategic opportunities and emerging technology solutions into pragmatic executable plans aligned with corporate blueprint and standards.

Responsibilities

• Own delivery of IS/Automation project portfolio with portfolio planning, resource and risk management, and financial management

• Anticipate, evaluate, and resolve multiple simultaneous project issues, delays, and problems

• Perform cross system assessments, feasibility analysis, and scope projects; prioritize and recommend optimal solutions

• Translate strategic and emerging technology opportunities into executable plans using corporate blueprint/standards and business drivers

• Manage relationships with peers, IS service owners, business partners, enterprise IS service partners, and vendors

• Communicate with multiple organizational levels; highlight issues and propose solutions

• Elicit and analyze business customer needs and convert them into functional design

Requirements

Basic Qualifications:

• Doctorate degree and 2 years of Information Systems, Manufacturing Process automation/Information system experience

• OR Master's degree and 4 years of Information Systems, Manufacturing Process automation/Information system experience

• OR Bachelor's degree and 6 years of Information Systems, Manufacturing Process automation/Information system experience

• OR Associate's degree and 10 years of Information Systems, Manufacturing Process automation/Information system experience

• OR High school diploma / GED and 12 years of Information Systems, Manufacturing Process automation/Information system experience

Preferred Qualifications:

• Demonstrable experience in a manufacturing environment (Pharmaceutical or Biotechnology industries)

• Experience with Automation/Process Control System (PCS)

• Experience with Data Historian and/or Manufacturing Execution System (MES)

• Experience with laboratory systems and/or IS platforms

• In-depth knowledge and hands-on coding experience of Emerson Delta V Platform

• Hands-on coding experience on Rockwell FactoryTalk and Rockwell PLCs

• Aveva PI Data Historian knowledge

• Kneat platform based C&Q documentation development knowledge (plus)

• Additional experience with Korber MES (plus)

• Understanding of GAMP software development lifecycle

• Understanding of ANSI/ISA-S88 and S95 standards/methodologies for PCS and MES implementation and Systems Integration meeting Operations requirements

• Exposure to PAT, APC, AR/VR, Location tracking, Control tower, IIoT, IDA (advantage)

• Familiarity with software development lifecycle methodologies and 21 CFR Part 11

• Experience with validation and change control methodology

• Hands-on experience with computerized systems including troubleshooting, reliability and performance improvements

• Good interpersonal skills; collaborative team-based environment

• Understanding of cyber security and manufacturing network principles applied to operations technologies

• Ability to lead and influence multi-functional teams

Benefits

• Comprehensive employee benefits package: retirement and savings plan with generous contributions; group medical, dental and vision coverage; life and disability insurance; flexible spending accounts

• Discretionary annual bonus program (or sales-based incentive plan for field sales representatives)

• Stock-based long-term incentives

• Award-winning time-off plans

• Flexible work models where possible (check job posting)

• Total Rewards Plan includes work/life balance and career development opportunities