Principal Engineer

Level to be determined based on candidate qualifications:

Senior Engineer level:

Steriles Fill Finish facility Senior Engineer. Works with area maintenance department to support all priorities of repairs and improvements. Established, technically competent professional who independently develops and implements solutions.

Primary Responsibilities:

• Leads projects of larger scope (or portions of projects) and is often called upon by peers for guidance.
• Directs project or discipline teams.
• Meets customer needs in support of business goals.
• Coaches and teaches junior members of the department and provides input to performance evaluations.
• Makes independent decisions within defined areas of responsibility.
• Serves as a consultant to management within a specified area/discipline.
• Advances technical project proposals to senior management, following through to successful completion.
• Influences commitment of resources at divisional/departmental level.
• Interacts regularly with senior technical peers and colleagues. Sets levels of technical and/or regulatory performance for others at the organization to emulate. Develops network of external contacts appropriate to job. Performs assignments in more than one location. Formulates and manages own career path. Designs and operates manufacturing technology for the organization. Supervises quality control and oversees the fulfillment of FDA regulations.
  
  Candidate must have excellent interpersonal, technical writing and communication skills. Strong technical and problem-solving skills in a manufacturing environment.

• Experience in Minitab, Microsoft Office applications, and AutoCad or Solidworks highly preferred.

  
  
  Requirements:
  Bachelor’s Degree in engineering or related field.
  Minimum of 6 years of experience. Experience in Biotech or Chemical industry highly preferred.
  
  

Staff Engineer level:
Steriles Fill Finish facility Staff Engineer. Works with area maintenance department to support all priorities of repairs and improvements. Fully qualified professional: Demonstrates consistent application of technical knowledge and/or regulatory knowledge in all/some of the following Engineering disciplines; Mechanical, Electrical, Chemical and Process. Develops and implements solutions. Leads projects of larger scope (or portions of projects) and is often called upon by peers for guidance. Directs project or discipline teams. Meets customer needs in support of business goals. Coaches and teaches junior members of the department and provides input to performance evaluations.

Primary Responsibilities:

• Sought for counsel within field of expertise for all/some of the following areas of Engineering: Mechanical, Electrical, Chemical and Process, depending on the department. Assigned to one or more areas of Engineering within the company: Project, Plant & Reliability or Utilities.
• Makes independent decisions within defined areas of responsibility.
• Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.
• Develops technical engineering standards. Resolves conflicts within areas of responsibility.
• Serves as a consultant to management within specified area/discipline.
• Advances technical project proposals to senior management following through to successful completion. Chairs inter/intra-departmental teams.
• Interacts frequently with senior technical peers. Sets levels of standard technical performance for others. Utilizes flexible leadership skills.
• Influences commitment of resources at division/department level.
• Excellent interpersonal, technical writing and communication skills. Strong technical and problem-solving skills in a manufacturing environment. Designs and operates manufacturing technology for the organization. Supervises quality control and oversees the fulfillment of FDA regulations.
  
  Candidate must have strong knowledge of engineering principles in all or some of the following areas; Mechanical, Electrical, Chemical and Process. Excellent project management skills. Excellent oral and written communication skills with the ability to present complex ideas in clear and simple terms. Strong problem-solving skills. Ability to analyze and identify areas for improvement. Interacts outside the technical area with Administration & Human Resources Departments and counterparts in the organization. Solidifies formulation of career plans. Utilizes flexible leadership skills. Demonstrates integrity and a firm commitment to company beliefs and values. Influences regulatory agency actions and community outreach activities.

Requirements:
Bachelor's Degree in Engineering or related field.
Professional registration and/or certifications as appropriate.
Minimum 7 years of related experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred.

Principal Engineer level:
Steriles Fill Finish Principal Engineer. Works with area maintenance department to support all priorities of repairs and improvements. Fully qualified professional: Demonstrates consistent application of technical knowledge and/or regulatory knowledge in all/some of the following Engineering disciplines; Mechanical, Electrical, Chemical and Process. Prepares budgets for area of responsibility, obtains approval and ensures budget adherence, is authorized to approve expenditures based on guidelines. Plans and organizes cross-functional activities. Participates in human resources issues and is responsible for performance management in area of responsibility. Continuously participates in technical and non-technical training. May include staff reporting to this position. Responsible quality compliance. Supervises or oversees shift(s)/smaller operation and/or project/assignment including safety, regulatory and environmental compliance. Assures continuous improvement of processes.

Primary Responsibilities:

• Sought for counsel within field of expertise for all/some of the following areas of Engineering: Mechanical, Electrical, Chemical and Process, depending on the department. Assigned to one or more areas of Engineering within the company: Project, Plant & Reliability or Utilities.
• Ensures compliance with company and regulatory policies and procedures and is responsible for optimum use of staff and technical capabilities within defined areas.
• Focuses on fostering a best in class environment for the development, manufacture and regulation of biological products through availability and analysis of data, process understanding and Critical Quality Attributes (CQAs), utilization of process capabilities (maximize yield and throughput within CQA), continuous quality verification and continuous improvement.
• Develops technical engineering standards. Resolves conflicts within areas of responsibility.
• Serves as a consultant to management within specified area/discipline.
• Advances technical project proposals to senior management following through to successful completion. Chairs inter/intra-departmental teams.
• Interacts frequently with senior technical peers. Sets levels of standard technical performance for others. Utilizes flexible leadership skills.
• Influences commitment of resources at division/department level.
• Makes independent decisions within defined areas of responsibility.
• Provides technical/non-technical report status on budgets and schedules.
• Implementation of efforts that evaluate the feasibility of online instruments to monitor key critical attributes, performance of proof of concept studies on new applications and identification of opportunities to optimize current processes. Identifies new process analytical opportunities in cooperation with Business Units, Technology, QO and Bio-Analytic. Supports business case development and testing of analyzers. Leads installation, qualification and integration into process controls. Develops objectives and implementation plans for a team of engineers. Manages cost center. Works with a core team and management to continue to develop and define the approach for the organization. Participates in identification, justification, development and implementation of strategies and communicates the ideas to the core team. Maintains established organizational presence in industry through conference participation and external networking.
  
  Candidate must have strong knowledge of engineering principles. Excellent project management skills. Excellent oral and written communication skills with the ability to present complex ideas in clear and simple terms. Strong problem-solving skills. Ability to analyze and identify areas for improvement. Interacts outside the technical area with Administration & Human Resources Departments and counterparts in the organization. Solidifies formulation of career plans. Utilizes flexible leadership skills. Demonstrates integrity and a firm commitment to company beliefs and values. Influences regulatory agency actions and community outreach activities.

Requirements:
Bachelor’s Degree in engineering
Professional registration and/or certifications as appropriate.
Minimum 8 years of experience. Experience in Biotech, Pharmaceutical or Chemical Industry preferred.

Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. Stands for 2-4 hours per day. Frequent movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Occasionally bends and twists neck and waist. Frequent foot movements. Color perception/discrimination, depth perception and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs routine tasks by following a set of written or oral instructions/procedures.

EEO/Minorities/Females/Disability/Veterans

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