Job Details

Department

Facilities and Engineering

Job Title

Engineering Associate

FLSA Status

Exempt

Role

N/A

Sub Role (If any)

N/A

Reports To

Validation Manager

1. Role Purpose:

Responsible for developing, writing, reviewing and executing Installation, Operational and Performance Qualification documents for Manufacturing, Packaging and Facility Equipment.

2. Key Duties & Responsibilities:

• Identify and execute special projects that will bring cost savings through PPI (Practical Process Improvement) programs. Drives practical process improvements in maintenance, engineering and facilities through Six Sigma and Lean manufacturing techniques.
• Implement projects to drive business growth and profitability. Identify production needs and execute process improvements.
• Excellent collaborative skills, working with department supervisors and other departments using verbal and written communication to resolve product and process problems.
• Document projects using Engineering Design Reviews, Change Control or other tools needed to maintain the qualified status of manufacturing and other processes.
• Develop, write, review and execute Installation, Operational and Performance Qualification documents for Manufacturing, Packaging and Facility Equipment.
• Develop, write, review / update Standard Operating and / or Preventive Maintenance Procedures.
• Learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
• Design and install control system upgrades to new and existing equipment.
• Manage projects for various department remodeling and equipment upgrades.
• Design Machine Controls and PLC Logic and program SCADA systems.
• Work with manufacturing teams to machine improvements.
• Identify and provide justifications for Capital Projects.
• Comply with FDA guidelines/Company Policies of Data Integrity.
• Other duties as assigned.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Education Requirement

Specialization (If any)

B.S. in Engineering or related field preferred

Experience Requirement

N/A

5. Technical competencies/ Certifications/ Licenses:

Technical competencies

• Preferred to have 3-5 years technical experience that includes pharmaceutical manufacturing, and project management preferred
• Ability to manage and plan multiple projects
• Analytical skills, good problem-solving technique and data analysis skills with Excel
• Excellent communication skills, both written and verbal
• Outgoing and collaborative in nature
• Detail Oriented

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A