Senior Engineer

EOE Statement
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, protected veteran status or any other characteristic protected by federal, state, or local law.

About the Organization
Mikart is a contract development and manufacturing organization (CDMO) supplying a comprehensive suite of services across the drug development and commercialization continuum. Wherever you are in the journey from conceptualization to maximizing market adoption, Mikart is your seasoned industry partner - we've been delivering the highest quality products surpassing the most exacting client standards for over 45 years.

Category
Engineering

Description

Job Purpose

The Senior Engineer position for Mikart, LLC will be responsible for assigned engineering projects, this includes providing the managerial, organizational, and technical expertise to direct and coordinate installations, upgrades, large scale maintenance repairs, and other improvement projects. The position is also responsible for implementing improvements to increase equipment efficiency and prevent obsolescence. In addition, this position also supports efforts to maintain the validated state of all applicable equipment, utilities, and facilities.

Accountabilities

For leadership of assigned projects through all phases of projects. (Conceptual design, detailed design, equipment procurement, construction, installation, start-up, commissioning, qualification and handover).

For maintaining the applicable equipment, utilities and facilities in a validated stated by performing periodic qualification reviews, requalification, or other assessments.

For ensuring all project assignments are completed within budget and on schedule.

For managing multiple projects with well-documented and organized project management skills to problem solve and support company objectives.

For conducting and documenting investigations on equipment, utilities and facilities using structured problem-solving techniques including identification of root-cause and effective preventative actions.

Essential Job Functions

• Plan, organize, and lead engineering projects; including identifying goals, objectives, methods, resources, communication, and dates for completion of engineering activities and tasks.
• Organizing resources to achieve the goals within a defined timeline.
• Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions.
• Lead project teams comprised of contractors from various crafts as well as members of internal company staff. This position will maintain compliance with all company standard operating procedures (SOPs) and applicable cGMP, OSHA, EPA, and local government regulations.
• Prepare engineering documentation for equipment procurement (e.g. URS, DDS, FAT, SAT) as well as equipment installs (e.g. IQ, OQ) and process validations (e.g. Cleaning Qualifications, Process Qualifications).
• Implementing departmental policies, programs and procedures.
• Conduct and/or coordinate qualification activities on equipment, utilities and facilities.
• Prepare and/or review qualification final reports.
• Support the development, review, and approval of calibration and maintenance activities on new and existing equipment, utilities and facilities.
• Management of the company assets within the Computerized Maintenance Management System (CMMS), Computerized Calibration Management System (CCMS), and Enterprise Asset Management (EAM).
• Assist in the generation, revision, and/or training of Standard Operating Procedures.
• Assist with maintaining facility drawings and issue facility change controls.
• Assist and participate in the scheduling, design, and execution of other special studies as required.
• Assist Director, Engineering and Maintenance in other areas as directed.

Position Requirements

Functional Competencies

Knowledge of FDA regulated industry requirements, Good Manufacturing Practices (cGMP), Environmental Monitoring System (EMS), Computerized Maintenance Management System (CMMS), Computerized Calibration Management System (CCMS), and Enterprise Asset Management (EAM), managing personnel, and EHS required.

Excellent written and oral communication, coaching, and mentoring staff skills.

Excellent ability to read and interpret technical information, engineering design, ability to read and understand equipment specifications and drawings, and ability to track and trend data analysis are required.

Knowledge of dry and wet blend granulations, including fluid bed granulates, high shear granulators, blenders, mills, multiple tablet presses, and tablet coaters.

Knowledge of packaging equipment systems, such as vibratory fillers, slat fillers, cappers and labelers.

Knowledge of Manufacturing process engineering principles and practices.

Knowledge of Engineering and business computer hardware and software.

Key Characteristics

• Demonstrated proficiency in written and verbal communication
• Ability to multitask and prioritize.
• Solid analytical and problem solving and decision-making skills coupled with the ability to work both independently and in a team environment.
• Strong documentation and organizational skills; ability to prioritize and manage through complex processes/projects.
• Detail oriented and concern for standards and compliance are essential.
• Must display attention to detail and the ability to handle multiple priorities.

Education and Qualifications

• Bachelor's degree in Industrial Engineering, Mechanical Engineering or applied science
• Minimum of 2 years' experience in a GMP environment, or other appropriate combination of education and experience.
• Sound knowledge of principals and applications of cGMP's and associated regulations in a pharmaceutical setting is a plus.
• Fluency in the English language.
• Well-developed technical writing skills.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to stand; sit and stoop, kneel, crouch, or crawl. The employee is occasionally required to walk. The employee must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and risk of electrical shock. The employee is occasionally exposed to fumes or airborne particles; toxic or caustic chemicals and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to: safety eyewear, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc.

Salary
Mikart, LLC offers a competitive compensation program and comprehensive benefits package to our employees.

This position is currently accepting applications.