Job description

Ascent Pharmaceuticals, Inc. is a fast growing generic pharmaceutical company located in Long Island, NY. Our core business is in the areas of Development, Manufacturing, Marketing and Distribution of high quality and cost-effective generic prescription medicines. Ascent has drug product development and commercial operations within its 350,000 square feet area. Ascent has multiple positions available in this area.

Engineering Validation Specialist: The Engineering Validation Specialist is primarily responsible for supporting the validation and qualification programs associated with manufacturing and facility related GMP critical and non-critical equipment and systems. The Validation/Qualification Engineer ensures that all department responsibilities are performed and documented accurately, timely and in compliance with SOPs, GDPs, cGMPs and FDA requirements.. This position works in a manufacturing environment.

Responsibilities:

• Assists and coordinates equipment, process and facility qualifications.
• Develops critical validation lifecycle documentation to support the qualification/validation of equipment, processes and facilities (e.g.IQ, OQ and PQ protocols, Operational SOPs, PM SOPs, Change Controls, User/Functional/Design Specifications, etc).
• Coordinate and complete validation tasks in support of new and existing equipment, facility, and utility qualifications as well as cleaning validations.
• Prepare and review validation documentation
• Analyses validation data
• Participate in risk assessments in support of validation activities.
• Familiarization and maintains knowledge of current industry practices and relevant pharmaceutical regulations.
• Updates and maintains Qualification Program SOPs, forms, records to meet cGMPs and local, state and federal regulatory requirements.
• Creates, maintains and reports progress against validation project schedules.
• Collects and organizes technical specifications, data and information required for construction projects.

Qualifications:

• Bachelor’s Degree in a Science or Engineering Field or 2 years of experience in regulated (pharmaceutical/ biotechnology) environment.
• Demonstrated technical and organizational skills to support engineering and maintenance.
• Strong understanding of cGMPs, FDA, OSHA, and other local, state and federal regulatory requirements associated with pharmaceutical manufacturing facilities.
• Computer literacy education

HOW TO APPLY

Apply through Indeed! For more information, visit our website at www.ascentpharm.com where applicants can upload their resume and cover letter outlining how they meet the specific requirements of the position.

While we sincerely appreciate all applications, only those candidates selected for interview will be contacted.

Ascent is an “EOE/Minority/Woman/Veterans/Disabled Opportunity Employer” and nothing in this job posting or description should be construed as an offer or guarantee of employment.

Job Type: Full-time

Job Type: Full-time

Pay: $50,000.00 - $60,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime
• Weekend availability

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Central Islip, NY 11722: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Validation: 1 year (Preferred)

Work Location: In person

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