MES Engineer 2

Job Title: MES Engineer
Job Duration: 6 Months Contract
Job Location: Portsmouth, NH

Job Description Summary:

• Responsible for overseeing and executing MES validation activities related to the gLIMS implementation. This role ensures that all validation deliverables are completed on time and in full compliance with global guidelines and standards.
• Responsible for supporting activities such as requirements gathering, testing, integration and implementation of Manufacturing Execution Systems (MES) in conjunction with gLIMS. Position is expected to operate with some supervision and some autonomy.

Job Description:

• Lead gLIMS - MES interface validation activities and ensure timely completion and approval of all validation- related deliverables and documents.
• Collaborate closely with the Site Change Manager and Automation SME to ensure all impacted local MES/LIMS SOPs and processes are updated or replaced and compliant with global and local quality standards and gLIMS process SOPs.
• Work closely with gLIMS/MES leads, system users and process owners to develop and revise MES recipes in a timely manner to support gLIMS interfacing.
• Configure production recipes using a library of objects if required.
• Execute test scripts (design , execution, simulation, etc.) with support and guidance from supervisor / Validation SME
• Ensure the validation process meets regulatory and quality standards.
• Perform other duties as assigned.

Degree (preferred)

• Bachelor of Science
• Applicable STEM field or Computer Science with relevant experience

Requirement:

• Automation, QC, Validation
• Pharma/Biotech
• 5-10 years

Qualification:

• Proficiency in using MES / LIMS or similar systems and familiarity with quality standards and regulatory requirements
• Extensive experience in validation processes.
• Strong understanding of **** CSV validation guidelines, templates, and SOPs.
• Excellent project management skills to lead and coordinate MES validation activities.
• Effective communication and collaboration skills to work with various stakeholders.

Competencies & Behaviors:

• Learns from experience, errors and setbacks
• Helps others learn from experience to develop themselves
• Challenges the status quo and looks for opportunities to make improvements in his/her area of the business and beyond
• Embraces new initiatives and drives successful implementation in his/her area
• Adapts thinking and behavior to support change
• Takes personal responsibility for promoting change in his/her area
• Understands how to effectively engage others in the change processes

Business Acumen:

• Sets and delivers on individual and team objectives that support the company strategy
• Uses knowledge of his/her business area and related areas to make correct and timely decisions

Collaboration:

• Works in partnership as an active member of his/her team and cross- functional working groups
• Generously shares information and knowledge with others across teams and functions
• Actively seeks out and shares different perspectives from a broad network and implements alternative approaches
• Champions and role models the values of diversity and inclusion through everyday interactions in groups

Customer Focus:

• Proactively seeks to understand internal/external customer needs
• Develops insights that can be used to enhance customer satisfaction or other metrics
• Identifies when company and customer interests may not align and seeks effective solutions to resolve or escalate
• Manages internal and external customer relations professionally and effectively
• Uses systematic approaches to ensure customer key metrics are tracked and analyzed for continuous improvement

Driving Results:

• Establishes and consistently delivers on KPIs and challenging goals for him/herself (and team)
• Proactively shares credit for successes
• Helps peers (and team) overcome performance obstacles and challenges
• Secures buy-in from key stakeholders
• Ensures delivery excellence for own goals and those of his/her team
• Regularly solicits, assesses and addresses feedback
• Appropriately prioritizes multiple demands and leads defined work to successful conclusion on time

Leadership:

• Supports others in taking responsibility for a safe and sustainable environment
• Takes personal accountability for outcomes resulting from choices and behaviors of self and team
• Seeks and provides feedback to their team to support professional development
• Takes personal accountability for defining and implementing his/her own development and supports others to do same
• Creates a positive work environment for his/her team and demonstrates high integrity
• Ensures clear and direct 2-way communication within his/her team and other organization

Quality:

• Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant 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. Employee owns their own safety, the safety of their team and the safety of others.

Skills:

• Advanced technical knowledge of Quality control and manufacturing operations.
• Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
• Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
• Demonstrated ability to manage medium to large sized projects within required timeframes.
• Demonstrate ability for effective Planning, Organizing and Controlling competency
• Demonstrate sound decision making.
• Ability to work inter-departmentally and with customers.
• Demonstrates role model behaviors for GMP and Safety behaviors
• Strong written and verbal communication skills
• Ability to work in MS Project, Word, Excel, PowerPoint

MES of record is Syncade (DeltaV MES). This is not a recipe author role.
This is a systems integration role, connecting Syncade to other software tools like LabVantage LIMS (referred to as gLIMS) and other systems.