Job Description
Seeking a senior Controls Systems Engineer with substantial expeirence. A team member is moving to a different internal team for 6 months. Role will support Continuous Improvement initiatives. Some minimal PLC Programming is conducted, but the team has those tasks covered. Candidates with PLC Programming experience would be ideal. The manager is looking for candidates that have worked on busy projects with DeltaV rather than people that have just supported steady state environments. 10 years of Steady State experience could translate to 2 years of experience in a CDMO or Start up environment with implementation projects. Some flexibility with on-site, could be onsite 1 week per month for a very experienced person, more to full onsite would be required for someone with less experience.
Support ongoing client operations through technical assistance as it relates to the manufacturing and process automation systems. Provide a technical resource to operations customers to ensure that instrumentation and automation systems are designed and operating to meet production needs.
Responsibilities:
Planning and execution of plant projects involving complex equipment changes and significant process improvements
Controls lead for tech transfers
Support resolution of equipment breakdowns and quality issues in the suites
Provide SME support to Manufacturing and other departments for the design and operation of process automation equipment
Conduct troubleshooting and technical analyses on manufacturing equipment and processes automation systems including PI data analyses, review/troubleshooting code, etc., both during normal business hours and as part of an on-call rotation
Performs all work safely and meets the requisite training requirements
Participates in IPT/JPT in addition to other meetings as the Controls representative
Participates in audits and inspections as Controls SME if required
Owns and executes completion of CAPA actions
Initiates change controls and participates in all aspects of the change controls process Review SOPs, Functional Specifications, and work instructions
Remain up to date on all assigned training activities
Additional Responsibilities:
Budget - May be responsible for monitoring timelines and established budgets to ensure that project deliverables are met on time and that the budget is not exceeded.
Quality - Adherence to cGMPs is required at all times during the manufacture of APIs. All personnel own the quality of what they deliver and are responsible for notifying the applicable management member in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and related actions.
Safety- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Works safely in cooperation with other departments when troubleshooting manufacturing issues and is aware of dangers and potential kinetic energy sources.
Qualifications
Bachelor s of Science in an applicable engineering field or Computer Science.
Language Required: English (Ability Level 2 - Business Fluent).
Advanced level (5 10 years) in Pharma/Biotech or equivalent industrial automation. Supervisory or project management experience is preferred.
Competencies & Behaviors
Agility - Takes personal responsibility for promoting change in his/her area and helps others learn from experience to develop themselves
Business Acumen - Uses knowledge of his/her own business area and related areas to identify and develop operational/financial improvements
Collaboration - Works in partnership as an active member of his/her team and cross-functional working groups while also sharing information and knowledge across teams and functions
Customer Focus - Manages internal and external customer relations professionally and effectively while developing insights that can be used to enhance customer satisfaction or other metrics
Driving Results - Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time. Also secures buy-in from key stakeholders for projects and process improvements when required.
Leadership - Creates a positive work environment for his/her team and demonstrates high integrity. Takes personal accountability for defining and implementing his/her own development and supports others to do the same.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.