Job Description

If you are an experienced life science professional, or just starting your career, you need a resource that understands the unique skills of your profession. Alliance Scientific Solutions employs experienced, specialized recruiters that align themselves with our candidates and customers to establish long-term qualified partnerships that generate positive results.

Alliance Scientific Solutions is currently looking for a top performer in the area of Validation Engineering

Position Title: Process Validation Engineer
Status: Permanent- Full Time
Location: Cleveland, Ohio
Compensation:
Salary: $60,000-$80,000
Benefits Full Benefits
Relocation Assistance Available Yes
Interview Travel Reimbursed Yes
Willingness to Travel: Rare
Education: Requires a four year degree in an Engineering related discipline, or science related degree w/experience.
Experience: Minimum of two (2) years validation experience in the pharmaceutical industry.
Position Summary:

Validates manufacturing processes, cleaning procedures, equipment and media fills. Validation activities include writing and executing protocols that comply with plant, corporate and regulatory requirements.

Duties and Responsibilities:

Prepares, schedules and executes validation protocols. Designs testing strategy and methodology for the qualification and validation of products, cleaning processes, media fills, equipment, facilities/HVAC systems and utilities. Prepares final report following execution.

Reviews Standard Operating Procedures (SOP’s) and ensures the operational directions and parameters described in the SOP for equipment reflects validated conditions.

Supports quality investigations resulting from process deviations and provides CAPA support.

Requires the flexibility and dedication to conform to a work schedule in which the start times are extremely variable. Listed below are examples of conditions which frequently result in non-standard work schedule.

Working around the Production Department to gain access to production equipment which needs to be validated.

Emergency response to breakdowns of Production equipment.

Performance of critical validations during shutdown or other holiday periods.

Periodically working 2nd or 3rd shifts to meet aggressive timetables.

Requirements:

Requires understanding of cGMP regulations and industry standards regarding the validation of aseptic manufacturing processes.
Must be flexible to work off-shifts and weekends as validation execution schedule requires. May be required to occasionally work in confined spaces, sterile areas and noisy areas.

Must possess good computer skills, good technical writing skills and excellent written and oral communication skills.

Must possess analytical skills and be able to prioritize projects, make decisions and determine appropriate courses of action with minimal assistance.

Requires good interpersonal skills as well as the ability to multi-task and work under pressure and timelines.

Must be knowledgeable in windows based software programs

Finding a new job or transitioning to a new position within today’s competitive and every changing scientific market takes networking, connections, and timing. Why not enhance your ability to find that key opportunity by aligning yourself with an Alliance recruiter who has ties into the most progressive and growth oriented organizations? Alliance Scientific has partnerships with Pharmaceutical, Food & Beverage, Clinical Lab, Biotech, and Industrial Manufacturing companies.

Benefits

Dental, Paid Time Off, Holidays, Flexible Spending, Medical, Life, Health Savings Account, 401K, Prescription

Contact Details

Name: Alliance Staffing Solutions