Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Sr Engineer

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity.

Responsibilities:

General:

• Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
• Develop engineering policies and procedures that affect multiple organizational units.
• Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
• Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
• Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
• Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
• Application of mature engineering knowledge in planning and conducting projects.

Other functions may be assigned.

Design Engineering:

• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
• Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
• Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
• Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
• Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project.

Qualifications:

• Doctorate OR

• Master's + 2 years of Engineering experience OR

• Bachelor's in Engineering + 4 years of Engineering experience.

  Competencies/Skills

• Working knowledge of pharmaceutical/biotech processes.
• Familiarity with validation processes.
• Familiarity with documentation in a highly regulated environment.
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope.

Preferred Qualifications:

• Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
• Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations.
• Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization.
• Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
• Lead the implementation of equipment improvements projects.
• SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations.
• Support equipment troubleshooting within the functional area or in the scope of technical expertise.
• Support deviation process and define, implement and own CAPAs associated to equipment within area of expertise.
• Drives Environmental, Health and Safety compliance within the organization.

Demonstrated Skills in the following areas:

Negotiation, persuasion and facilitation. Collaboration. Project cost development. Conflict Resolution. Leadership and teambuilding. Management of contractors and vendors.

Demonstrated Skills in the following areas:

Schedule development. Facilitation. Collaboration. Basic project management. Completion and follow-up. Established expertise in at least 3 separate areas of engineering technology. Ability to independently determine when additional external resources are required to solve problems. Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope. Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach. Working knowledge of financial analysis tools. Ability to delegate and manage the project work of others.

Demonstrated Skills in the following areas:

Basic technical presentations. Personal Organization. Validation Protocol Writing. Dealing with and managing change. Technical (Equipment Specific). Analytical Problem Solving. Computer Literacy. Specialized equipment/process expertise. In-depth knowledge of validation processes and requirements as applied to new equipment installations. Interacts effectively with variety of communication and working styles. Ability to independently determine when additional internal resources are required to solve problems. Ability to handle multiple projects at one time.

Demonstrated skills in the following areas:

Problem solving and applied engineering. Basic technical report writing. Verbal communication. Comprehensive understanding of validation protocol execution requirements.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.