Process Engineer

This role is located in San Antonio. Direct hire Client will pay relo/interview expenses.

 

The Process Engineer is responsible for the evaluation of new or existing products by providing process (Compounding & Packaging) and equipment evaluations for feasibility, resource and cost estimating, documentation generation & review, execution of projects and engineering studies, and overall customer support as required.
1. Generate Request For Estimates (RFE’s) for Packaging and Compounding based on a specific product characteristics including all required equipment estimates.. 2. Provides recomendations for production equipment to Manufacturing. 3. Provides support to Project Engineering to coordinate and select process equipment 4. Provides support to Project Management and Commercial Operations with impact evaluation of product changes/modifications. 5. Writes and develops Operational SOP’s for startup and equipment operation. 6. Develops and executes change parts evaluations for new products and/or component changes. 7. Responsible for implementation of facility and production related project including all facets of Project Development, Project Execution and Project Closeout 8. Review and approve Packaging modules; develop first draft of Packaging Set-Up Modules 9. Support R&D Packaging Engineers in new product & process development and evaluation & coordination of Engineering Studies. 10. Provide support to QTS/Validation in documentation generation and execution; support Quality in investigations and corrective actions. Note:Within my areas of responsibility, understand and comply with all DFB Pharmaceuticals, Inc. safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations.

Education: Bachelor’s degree Bachelor’s degree (B.A.) in Engineering from four-year College or University.
Experience: 3 – 5 years Pharmaceutical Manufacturing (cGMP)
Language: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write speeches and articles for publication that conforms to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Math: Ability to comprehend and apply principles of advanced calculus, modern algebra, and advanced statistical theory. Ability to work with concepts such as limits, rings, quadratic and differential equations, and proofs of theorems.
Reasoning: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.

Validations Engineer

These roles are located in San Antonio.  Direct hire

 

Candidate will assume a leadership role in a highly motivated group within a leading contract manufacturing facility.  Major Job function includes the ownership and oversight of qualification and validation activities required to support the business and customers, including: the generation, execution, and development of the final reports for qualification / validation documents associated with cleaning, process, and packaging validation to support the manufacture of liquids and semi-solid pharmaceutical products.  The individual will be required to support and / or generate technical protocols, memos and other documents in support of the qualification, validation, change control and / or other quality engineering related tasks.  Projects range from stand alone equipment to expansion, new packaging lines and new product launch.

Coordinate and supervise cross functional resources in the   execution of validation cGMP projects and ensure compliance with FDA, ISO, EU   and any other appropriate regulations.

–       Provide   technical assistance for investigations into process/product issues in   support of the qualification / validation deviations and review of design   requirements for products and or equipment.

–       Schedule,   plan, and resource load of activities to support qualification / validations   efforts as needed, including assisting in process sampling, auditing and   technical review functions as defined within the company procedures, guidance   documents and industry practices. Strong communicational skills are required   to effectively support cross functional teams.

–       Assist and   support scheduling qualification/validation activities with cross-site   departments.

–       Interface   with clients and management as well as transfer discussions, timelines,   activities to team members.  This   includes the timely organization of team activities, determining priorities,   assignment of projects, etc.

–       Organize team   meetings, delegate assignments, and generate performance reviews.  The individual must be able to effectively   communicate expectations and objective, effectively motivate individuals, and   build team camaraderie.

–       Provide   expertise and leadership for projects involving facility, equipment/utility   qualification, and process, packaging and / or cleaning validation. Must   ensure all cGMP systems within the facility are within and maintain a   validated state.

As a multi-functional group, time management skills are a   must.  The individual must be able to   effectively manage personal activities as well as manage the time of the   group.  The candidate must be able to   report project status and team performance capability to cross functional   team members.

The candidate must be familiar with current industry   practices and guidelines including those required / outlined by the FDA, ISO,   EU and ICH.

The candidate MUST have direct experience independently   generating and executing protocols, review of data, and generating final   reports for cleaning, process and packaging validation.

The candidate MUST be an independent thinker and have a   strong understanding of industry regulations and guidance.

Application Development Manager

This role is located in Chicago, IL

 

Directs, manages, plans and administers the technical, operational support, and administrative activities for a systems analysis/programming team.
EDUCATION
The highest level of education desired for candidates in this position is a Bachelor’s degree or equivalent experience.
Required Knowledge/Experience:
* Experience with business intelligence/OLAP tools, such as Futrix, Cognos, Business Objects, or Microstrategy * Experience with SQL and/or SAS * Experience working with, manipulating and managing large databases * Healthcare data warehousing and analysis experience
Required Skills – Develop Best Practices for Application and Technology Implementation (Advanced) – Developing Software Solutions (Advanced) – Identify and Evaluate Technical and Strategic Solutions (Advanced) – Project Team Management (Advanced)
Desired Skills – Identify Business Value and Cost of Initiatives, Solutions, and Projects (Advanced) – Determine appropriate staff resource levels to support business strategy (Advanced) – Develop and implement strategic plans with vendors to meet with changing – future business requirements (Advanced) – People skills, ability to talk to and work with non-technical staff, strategize on future technical direction, participate in multi-departmental meetings with an understanding of the purpose, goals, and skill sets of those various departments. – Experience with Informatica, DART, or Datastage a plus. – Experience with Informatica, Datastage, or other ETL Tools a plus.

Senior Unix Administrator

This role is located in Denver. Direct hire

 

The Senior UNIX Administrator will provide technical leadership for the UNIX system administration team reporting to the UNIX Manager.  He/she will directly support the business by contributing in the areas of IT systems architecture and infrastructure design.
The Senior UNIX Administrator is responsible for the design, planning and maintenance of UNIX infrastructure systems and storage area networks.  These include over 250 UNIX and Linux servers, the production backup infrastructure, DNS, greater than 500 Terabytes of disk storage, hundreds of application services, core infrastructure services, disaster recovery operations, security and interoperation with Windows, Networking and remote systems.
The Senior UNIX Administrator will promote Abacus’ capabilities as appropriate, advancing Abacus products and services.  He/she will also work to leverage, integrate, and provide core services to high performance computing and storage resources as appropriate to enhance the performance, capabilities, and usability of systems at Abacus.
B. Key Accountabilities – Leads technical projects that are focused on introduction of new infrastructure and also have software application engineering implications. – Establishes criteria and performs technology evaluations, including lab analysis and proof of concept along with supporting analysis and documentation. – Provide company level productivity through stable UNIX and Linux hardware and software – Provide adherence to data retention requirements through consistent and reliable backup infrastructure – Ensure that all changes to UNIX and Linux production environment adhere to established Change Management procedures – Responsible for ensuring adherence to security policies, including regular security updates to UNIX and Linux systems. C. Metrics – System uptime and stability – Financial – Innovative and cost effective UNIX and Linux solutions Knowledge and Skill Requirements Skills:  Project Management, Resource Management and Budgeting.  Design and Architecture using industry best practice solutions that meet the need of the business.  Primary technologies include: Sun Solaris operating Systems 2.4 through current, RedHat Linux all versions, NIS, Bind (DNS), Sendmail, Sitescope, Veritas (Netbackup and Storage Foundation Suite, Storage Area Networks.
Demonstrated systems integration expertise. Successfully negotiates technical design and deployment strategy.
Works on unusually complex technical problems and provides solutions that are highly innovative and ingenious. Leads efforts to define, plan and design innovative solutions, including financial analysis of technical alternatives to meet business requirements.
Serves as the cross-platform technical subject matter expert and provides coordination and consulting support.  Leads technical projects that are focused on introduction of new infrastructure and also have software application engineering implications. Establishes criteria and performs technology evaluations, including lab analysis and proof of concept along with supporting analysis and documentation.  Frequently interacts with vendors to influence their products and services.  Responsible for briefing Sr. Management on topics ranging from risk analysis, financial implications, to crisis management.   Other: – Advanced verbal, written, and presentation skills — particularly the ability to communicate technical information to non-technical audiences. – Demonstrated ability to work with a wide variety of technical and managerial personnel to solve complex problems. – Experience working in a multi-business unit company environment. – Excellent selection, appraisal, and development skills. – Ability to interact effectively at all levels (staff, management, and customers) across diverse cultures. Strong customer, quality, and results orientation. – Ability to be an effective team member and proven track record of leading complex development and project teams.
Technical Responsibilities: – Design, deploy, monitor, maintain, develop, upgrade, and support new UNIX and Linux systems; hardware, software, and peripherals, including storage area networks and backup infrastructure. – Provide end-user services escalation requiring UNIX administrative assistance for CIT help desk services where necessary. – Keep current with the latest technologies. – Practice asset management for UNIX and Linux hardware, software, and equipment, and ensure that asset management policies are adhered to by the team.
Position Requirements: – Recognized expert technical knowledge of UNIX and Linux operating systems. – Recognized expert technical knowledge of current network hardware, protocols, and standards. – Proven experience in IT infrastructure planning and development. – In-depth knowledge of applicable data privacy practices and laws. – Strong understanding of project managements principles. – Excellent written and oral communication skills. – Excellent interpersonal skills. – Highly self-motivated and directed. – Keen attention to detail. – Proven analytical, evaluative, and problem-solving abilities. – Ability to effectively prioritize and execute tasks in a high-pressure environment. – Exceptional customer service orientation. – Extensive experience working in a team-oriented, collaborative environment. – 12 or more years of system administration experience on UNIX platforms. – 6 or more years of progressive IT project/program management experience.

Infrastructure Architect

This role is located in Irving, Tx  Direct hire

 

This individual with expert technical and analytical skills in enterprise systems architecture and software development, will be responsible for working with senior business and technical staff across all units in the company to formulate, maintain and communicate a cohesive systems architecture strategy.  A minimum of 8-10 years direct web development and software architecture experience are required.
ITIL, COBIT, Red Hat, CISSP, Enterprise Infrastructure Architect Certification Desired
RESPONSIBILITIES:
– Develops descriptions of systems and business functional boundaries – Develops and maintains the comprehensive systems architectures, frameworks and application interfaces – Works with senior IT staff and management to develop and maintain company technical processes and standards  (ITIL based) – Reviews and approves technical designs for conformance to standards and architectural requirements – Provides consultation and assists project teams in formulating solutions – Must be able to perform under tight timeframes and execute problem solving skills – Identifies and understands the key drivers that impact the business – Performs business and technical requirements analysis and review – Proactively learns about and evaluates emerging technologies (reviewing technical journals, team sharing, mentors, vendors, peer groups, special training) – Develops, monitors and enforces technical standards – Understands and leverages best practices of Information Technology – Establish technical specifications that facilitate easy, accurate coding or scripting/configuration – Develops information processing strategies and plans that add value and/or competitive advantage to customer – Executes risk assessment utilizing established methodologies – Develops relevant, repeatable criteria for assessing future risks and problems – Develops appropriate metrics to measure total system performance – Applies an understanding of the key vulnerabilities related to data transfer between internal/external systems to maximize data security and integrity
QUALIFICATIONS:
– Solid understanding and application of web services, SOAs, data base performance and networking – Solid understanding of UNIX/Linux Operating Systems – Red Hat, Solaris, AIX, Oracle Linux – Solid understanding of Clustering techniques and technologies supporting Oracle databases – Solid design and build experience of reference implementations of components and interfaces with new technologies – Solid understanding of currently used UNIX/Linux files systems – EXT2,3, GFS, NFS, XFS – Solid experience in designing for critical areas of security, performance, capacity and maintainability – Excellent design experience, including use of industry design patterns and best practices – Excellent understanding of software development lifecycle – Excellent written and verbal communication skills (emphasis on documentation) – Solid experience with data modeling tools and concepts – Solid understanding of server/application deployment techniques, methodologies, and tools – Previous Experience as a Systems or Application Architect
EXPERIENCE REQUIRED:
– Experience with Linux (RedHat). Experience with Migrations to Linux a big plus. Experience with Linux (RedHat). Experience with Migrations to Linux a big plus. – Performance Tuning, optimization, and advanced troubleshooting of systems Issues   – Strong Bash shell scripting, Perl etc. – Knowledge in Various Backup/Recovery Methodologies and Strategies – Familiarity with various tools and methods for administering the Unix Systems infrastructure – Deep & broad knowledge of full range of distributed messaging, email, active directory, middleware, application integration, web services, collaboration, knowledge & content management, systems management and related operating – System & supporting hardware and software technologies, architectural principles, design standards and options – Deep Technical knowledge of infrastructure services systems management and monitoring tools – Deep Technical knowledge of commonly used hardware and software products – Must possess a strong knowledge of vendor community for full range of infrastructure services architectures including but not limited to distributed messaging, email, DNS, middleware, application integration, web services,  collaboration, knowledge & content management, systems management and related operating system & supporting technologies along with broad knowledge of security best practices and intrusion detection and protection techniques and methodologies – Expert knowledge of distributed messaging, email, active directory, middleware, application integration, web services, web applications & portals, knowledge & content management, systems management and related operating system & supporting architectures (Microsoft Operating systems, IIS and .net framework, Unix operating systems, Linux operating systems, Active Directory, Exchange, SMS, DNS, LDAP, load balancing, Sun, Oracle, EMC, Cisco, F5 – Must have excellent architecture, design, operations support & troubleshooting skills (focus on systems integration and on the construction of messaging & middleware tools and frameworks to assist with systems, applications and data integration)
EXPERIENCE/EDUCATON:
– An undergraduate degree (BA/BS Computer Science) is required and a graduate degree is preferred Equivalent experience can be substituted for the degree requirement. – Red Hat, CISSP, Infrastructure Architect certifications  preferred

Healthcare PMP

Direct hire Arlington, Texas

Project Management experience, Healthcare experience highly desirable.  Ability to independently lead and manage people in Five or more years of experience in teams or large Demonstrated willingness to improve team capabili PMP Highly desirable ITIL foundations/ITIL service

Creating, managing, and continuously improving ITS governance processes – Creating, implementing, and improving standard Demand Management and Prioritization Processes including annual survey and tiger teams – Developing standard processes, templates, guidelines, principles, deliverables, checklists and other tools to support technology delivery. – Providing leadership and support to THR executives in the facilitation and delivery of enterprise program and project business requirements, process models and governance training programs. – Responsible for report back process to evaluate value delivered versus projected for enterprise programs and projects including but not limited to budget performance, resources consumed, costs incurred, and risk and change management – Responsible for working with Business Owners and Executive Sponsors to understand their responsibility and participation in the close loop “report back” phase of governance process – Responsible for working with Directors, managers, vendors, SMEs and others from all functional areas in ITS to determine technical scope of project requests – Ensure ITSM (IT Service Management) and ITIL (Information Technology Infrastructure Library) best practices are followed through all project lifecycle phases. – Leverage Enterprise Architecture to ensure technology and system selection is aligned with standards, system priorities, and strategic initiatives.

Director of Business Intelligence

This role is located in Salt Lake City, Utah

The Director of Business Intelligence will provide strategic direction and management for the Business Intelligence and Data Warehouse Systems. The position requires broad range knowledge of BI/DW technologies, development standards, delivery methods, and ability to drive Business value. This highly qualified candidate will report directly to the CIO and lead the BI team to develop and deliver leading-edge, business-focused solutions. The position requires strong leadership and business skills to build the strategic direction for the BI, DW and Finance/Supply Chain areas.

ESSENTIAL FUNCTIONS: Work closely and effectively with internal business partners, external consultants, and the vendor to ensure productive and adaptable working relationships. Actively participates in long-range strategy planning and manages policy development to address complex business issues. Ability to communicate complex technical solutions to executive leadership and peers. Responsible for all IT resources related to the effort including a staff of approximately 8 full-time technical professionals, in addition to consultant resources, and the matrix-management of numerous other professionals within the IT organization. Manage projects to aggressive time and dollar constraints. Develop and monitor financial plans and budgets. Facilitate management initiatives, process improvement, career and staff development and strategic planning within IT to support aggressive business growth. Extensive knowledge and proven success in the implementation of large Enterprise Data Warehouse and Business Intelligence solutions. Demonstrated success in working effectively with internal business partners, vendors, and consultant resources Requirements/ Qualifications: Bachelor’s or Master’s degree in computer science, information systems or other related field, or equivalent work experience; MBA preferred. A minimum of 10-15 years progressively responsible experience in Information Technology including at least 5 years effective senior-level people and project management experience in all phases of large, complex applications systems analysis, development and implementation Deep knowledge of the Oracle EBS apps and reporting using OBIEE enterprise platform required Experience with AR/AP/GL/Working Capital/Inventory/Purchasing reporting Demonstrated success in working effectively with internal business partners, vendors, and consultant resources Strong team building, IT staff development, change management, and general leadership skills Superior interpersonal and communications skills including the ability to be both directive and collaborative as appropriate to the situation