EPIC is a local Generic Pharma Company and if you are an energetic fast learner we are looking for you! We’re right here in Laurelton, Queens – an easy commute, a business casual, family/team environment, competitive salary, benefits, paid time off, employee activities, performance management program, flexible schedule and more!

If you see yourself as a proud contributor to the EPIC MISSION- providing patients with with a wide range of quality-infused and affordable medications developed and manufactured to the highest regulatory standards, and you fit the qualifications below, don't hesitate - send in your resume now! We're excited to meet you!

VALIDATION ENGINEER - PHARMACEUTICALS

Position Summary:

The primary purpose is to author and complete process and support equipment qualifications and required support documents (SOPs and final reports) on equipment associated with the manufacturing and packaging departments.

This is an Exempt, Salaried position.

Minimum Requirements:

• Bachelors Degree in Mechanical, electrical or industrial engineering from an accredited college or university
• Minimum 5 years pharmaceutical process development or pharma pre-validation experience.
• Experience preparing all types of pharma & regulatory documentation (BR, BOM, CC, protocols, summary reports, evalutaion reports.)
• Must possess knowledge on the operation of oral solid dosage processing equipment and the equipment required to support the operations of the facility, including HVAC systems, air compressors, air drying equipment, chillers and pumps.

MAJOR DUTIES/RESPONSIBILITES

• Maintain compliance of the validation program to ensure all equipment is qualified before it is used for any pharmaceutical process. Oversee equipment calibration and preventative maintenance program by setting and confirming scheduling of all outside contractors and maintaining the equipment database, reviewing and approving service support certificates/documents.
• Develop required support SOPs for all equipment qualified, maintain departmental compliance pertaining to departmental SOPs, weekly review and reporting of the environmental monitoring system.
• Oversee change control requirements for all projects and work orders.
• Work in conjunction with maintenance department to identify, recommend and implement the upgrade of current equipment and purchase of new withing regulatory requirements.
• Assist with onsite transfer projects and product scale-up activities.
• Analyze statistical data, product or functional specifications
• Write and revise validation protocols.
• Review and critique investigation reports, protocols, batch records and CMC documentation.
• Provide timely updates to management on status of all projects.
• Provide technical training and assistance to others
• Other ad hoc projects as assigned by Supervisor or Department Director.
• Candidates must be able to work effectively in a team environment to meet company objectives and commitments. Candidates should have excellent written and verbal communication skills, strong computer skills, and a good command of the English language.

Epic Pharma is an equal opportunity employer and offers a competitive starting salary and benefits package, including medical/dental/vision and 401k.

All candidates must be authorized to work legally in the United States on a full-time basis for ANY EMPLOYER. (No temporary visas or visa transfers.)

Benefit Conditions:

• Only full-time employees eligible

COVID-19 Precaution(s):

• Personal protective equipment provided or required
• Plastic shield at work stations
• Temperature screenings
• Social distancing guidelines in place
• Virtual meetings
• Sanitizing, disinfecting, or cleaning procedures in place

Work Remotely

• No

This Job Is Ideal for Someone Who Is:

• Adaptable/flexible -- enjoys doing work that requires frequent shifts in direction
• Detail-oriented -- would rather focus on the details of work than the bigger picture
• High stress tolerance -- thrives in a high-pressure environment

Job Type: Full-time

Pay: $92,000.00 - $115,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Disability insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• Day shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

COVID-19 considerations:
We have been following all CDC guidelines and more since March, because we are an essential business, pharma manufacturer.

Education:

• Bachelor's (Preferred)

Experience:

• Pharmaceutical Engineering: 5 years (Required)

Work Location: One location

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