Novex Pharma Limited is the leading global pharmaceuticals company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Primary Role:

This person will be a key player in the conceptual design, detailed design, specification, implementation, commissioning, trouble-shooting, and continuous improvement of automation and instrumentation for biopharmaceutical production and development facilities.

Candidate will be the primary liaison between Manufacturing and Facility clients and external engineering and vendor resources in the conceptual design, detailed design, specification, procurement, construction, and commissioning of automation systems for cGMP production facilities.   All system improvements will be made in conjunction with Manufacturing, Facilities, Manufacturing Technical Services, Quality Assurance, Validation and Regulatory. 

Must be able to work in a fast-paced multi-disciplinary environment.

Responsibilities:

Operational Support

Provides solutions to complex reliability and operational problems.

On call to support 24/7 production schedule

Owns and ensures timely closure of equipment related quality systems

Control System Support

Subject matter expert for the automation system

Owns and maintains the design and specifications for equipment and instrumentation

Develops automation related SOPs

Serves as subject matter expert for quality systems associated with automation systems

Evaluates new technologies for their application within a licensed GMP manufacturing facility

Maintains control system – system & application backups, virus protection, operating system patches, etc.

Assists in establishing preventative maintenance requirements and maintaining spare parts support system

Programming

Specifies and documents requirements

Implements requirements following Novex Pharma Limited engineering standard practices

Delivers automation design documentation

Programs, configures, and integrates new equipment into an existing PCS

Develops, reviews, and approves engineering standard practices through collaboration with partner departments – Validation, Metrology, Facilities, etc.

Ensure standards are followed and there is cross-site consistency for both in-house and contractor supported changes

Develop commissioning test plans for automation changes

Large Project Support

Provides budgetary and schedule estimates for the automation requirements of projects related to new and existing process equipment and control systems

Communicate project requirements to vendors to obtain proposals for hardware and software changes

Provides project team with automation requirements

Provides control system hardware and instrumentation requirements

Develops automation project documentation

Support process and facilities engineers in equipment commissioning

Pre/Post approve control system validation protocols

Troubleshoot and remediate exceptions found during validation

Assists process engineers in troubleshooting and remediation of failures

Assist in releasing control system for operation

Small Project Support

Owns and manages business and quality systems related to project

Provides and/or ensures generation of all supporting documentation (scope documents; approval slides; work orders; protocols)

Implements automation changes as specified in requirements documents

Uses project management skills to schedule, track progress, and make adjustments

Education & Experience Requirements:

Required education: Bachelors degree in Chemical or Electrical Engineering, or computer Science with appropriate industrial controls experience.

Required experience: minimum 5-8 years PLC, SCADA, and instrumentation configuration, programming, and design in a cGMP environment. 

Desired experience: Siemens PLC Step 7, iFix, iHistorian, OSI-PI, Honeywell DCS, Allen-Bradley PLCs, Delta V, BMS systems, Industrial Ethernet networks, Profibus networks and instrumentation

Familiarity with process systems and continuous processes.

Maintenance of Site Master Equipment History Files.

Other Requirements:

Ability to work at all Novex Pharma Limited MA locations (Berkshire)

Expected to carry phone device for on-call 24 hour support as required

Travel is currently limited to vendor visits including FAT’s and external commissioning. Travel may include international travel

Travel should not exceed 20%