Validations Engineer II

At PBI-Gordon Companies, and our subsidiaries PBI-Gordon Corporation, Pegasus Laboratories, and PetAg, Inc, our priority is people, pets, and the places they go. As employee owners, we support each other in building our careers as well as our companies. Our foundation is rooted in integrity, innovation, partnership, and pride. Come grow with us!

Job Summary:

The Validation Engineer II is responsible for process and product validation from equipment design to FDA approval and continued process verification. This position manages projects with Operations for the commissioning and qualification of equipment to maximize efficiency, safety, continuous improvement and apply lean manufacturing principles and techniques.

Primary Responsibilities/Activities:

• Oversee manufacturing equipment and facility commissioning projects including design, selection, and qualification. Develop protocols and write reports; to appropriately design the protocols, must be able to understand the purpose and objective of the study. Able to write and execute IQ, OQ and PQ protocols against project timelines. Has effective organization and time management skills. Multi-tasks well, delegates appropriately and considers others when planning. Develops effective plans, anticipates problems and looks for contingencies.
• Supports project technical development (Manufacturing Controls), from formulations to approval and launch as it applies to project design. Works with Formulators during laboratory batches to understand the process. Is able to navigate complex projects and view problems as opportunities. Shows confidence in ambiguous and stressful situations. Solicits and welcomes feedback from others.
• Able to design and perform the execution of sampling and sample preparation in support of cleaning, process, and packaging validation protocols. Must be able to analyze and review raw data and interpret results. Write final reports in accordance with industry and company standards. Able to build strong relationships and relate well with the different departments to reach common corporate goals.
• Managing and monitors assigned product validation projects including cleaning and manufacturing processes. Utilize a risk-based approach to establish and maintain the validation program specific to product.
• Responsible for project planning and justification; works with various departments to develop project budgets and timelines to manage the project effectively. Identifies and translates priorities into clear, actionable goals and tactics.
• Accountable for training manufacturing and production personnel on new equipment, cleaning procedures, and manufacturing processes. Build strong relationships and relate well with others to drive results to meet personal, company and corporate goals.
• Shows personal commitment and takes actions to continuously improve. Accepts opportunities that broaden capabilities. Applies what has been learned to improve future experiences for self, others, and company.
• Other duties as assigned.

Qualifications:

• Education: BS with 2-5 years of relevant experience or MS or PhD in Chemical or Mechanical Engineering or a related discipline.
• Experience: Must have 2+ years Pharmaceutical Process Development and Validations experience, 5+ years is preferred.
• Specialized knowledge or training: Experience with Process Validations, Cleaning Validations, Scale-up, and equipment qualifications. Experience with performing IQ, OQ and PQ functions for equipment used on different products (tablets, solutions, or topicals), Statistical process performance and Project Management are a plus.
• Other Skills: Strong Technical writing and documentation skills are necessary (cGMP, protocols, reports, OOS investigations, and laboratory notebook documentation).
• Travel required in this position 0-10%

Physical Requirements:

Must be able to climb into confined spaces and able to lift 50 lbs. (ie. Swabbing tanks, utilities mezzanines) and stand for extended periods of time.

PBI-Gordon Companies and its subsidiaries are proud to offer a comprehensive benefits package to eligible, full-time employees who work 30 hours per week or more. Full-time employees will become eligible to participate in benefits on the first of the month following their start date, unless stated otherwise below. (Note: Interns do not qualify for eligibility.)

Medical Insurance

We are committed to helping you and your dependents maintain health and wellness by offering voluntary, competitive medical insurance and prescription drug plan options.

Dental Insurance

Choose from two voluntary dental plans that are designed to help protect you and your dependents' oral health.

Vision Insurance

Our voluntary vision insurance plan is designed to help protect you and your dependents eye health. Coverage is available for eye exams, frames, lenses, and contact lenses. Employee owners are responsible for 100% of the cost of this plan.

Life Insurance with Accidental Death & Dismemberment (AD&D)

We offer a company-paid $50,000 life insurance policy with AD&D. You also have the opportunity to purchase additional life and AD&D insurance for yourself, your spouse and/or your dependent children. The cost for this coverage is based on the amount you elect and your age.

Short- and Long-term Disability

Our company-paid short-term and long-term disability plans to provide income replacement in the event you are not able to work due to illness or injury. Short-term disability will provide 70% income replacement up to $1,350 per week and long-term disability will provide 60% income replacement up to $5,000 per month.

Employee Assistance Program (EAP)

EAP Services are company paid to benefit all employee-owners and their families. EAP provides up to six free counseling sessions to help you and your family members manage life stressors, solve personal or relationship concerns, and achieve your goals.

Flexible Spending Account (FSA)

Flexible Spending Plans offer employee-owners the option to set aside pre-tax monies into a medical reimbursement or dependent care account to help pay for out-of-pocket medical, dental or vision expenses or day care costs. The maximum contributions are determined by the IRS and adjusted annually. This is a use-it-or-lose-it account, meaning any funds remaining in the account following the close of the plan year will be forfeited.

Pet Insurance

We love our pets! Pet insurance options for your furry friends is offered through the ASPCA. Employee-owners can enroll and pay premiums directly to ASPCA.

Paid Holidays & Paid Time Off (PTO)

Everyone needs time off to rest and recharge! Paid time off includes Regular PTO, Personal PTO, and specified paid company holidays. * The amount of paid time off (PTO) depends upon the employee's position and years of service.

Employee Stock Ownership Plan (ESOP)

We act like we own the company because we do! An ESOP provides employees with an ownership stake in the company. It's an additional form of compensation directly tied to PBI-Gordon Companies financial success. All regular employees are eligible to participate in the ESOP the first of the month following 30 days of service. PBI-Gordon Companies contributes approximately 18% of total compensation annually with a six-year vesting schedule. Our ESOP is more than a benefit, it is a key part of a culture, and it can provide significant rewards in retirement!

401(k) Retirement Savings Plan

Saving for retirement is one of the most important financial decisions you can make. We offer a 401(k)-retirement savings plan to assist employees with this important financial goal. New employee owners are eligible to participate the first of the month following 30 days of employment. We provide a company match of 100% up to 3% deferral with a three-year vesting schedule.

Fitness Reimbursement

We believe regular exercise helps improve overall health and job performance. PBI-Gordon will reimburse up to a maximum of $300 annually for gym/fitness memberships.

William Everett & Mary Ellen Mealman Scholarship Fund

Children or grandchildren of employee-owners may apply for a scholarship under the William Everett & Mary Ellen Mealman scholarship fund. Applicants are awarded based on financial need, academic achievement, and involvement in extracurricular/community activities.

Tuition Reimbursement

After one full year of employment, employee-owners are eligible for tuition reimbursement for bachelor's level coursework related to their current job or any future job offered at PBI-Gordon Companies.

Parental Leave

Company paid parental leave is offered to employee-owners following the birth of a child or the placement of a child with an employee in connection with adoption, foster care, or surrogacy. This policy will run concurrently with Family and Medical Leave Act (FMLA) leave, as applicable.

If you are a California resident, you have rights under the California Consumer Privacy Act (CCPA).

Please see our CCPA disclosure for more information.

Employment is contingent upon and may not begin until the successful completion of a pre-employment background check and drug screen. PBI-Gordon and its subsidiaries participate in E-Verify to confirm the identity and employment eligibility of all persons hired to work in the United States. For more information about E-Verify, including your rights and responsibilities, please visit the E-Verify Website.