Annual Wage Range: [[95,000]]  - [[105,000]] 
Other Compensation:  Eligibility for the Short-Term Incentive program and other applicable bonuses 
Benefits: U.S. Employee Benefits Summary (grace.com)

Final salary and compensation will be based on several factors including candidate qualifications and experience, geographical location, market, and business considerations.

 

 

Grace, a Standard Industries company, is a leading global supplier of catalysts, engineered materials and fine chemicals. We provide innovative products, technologies and services that our customers use to manufacture everyday products like renewable fuels, pharmaceuticals, toothpaste, cosmetics, food packaging, beer, edible oils and more. Our thousands of employees help shape a better future at our global headquarters in Columbia, MD and locations worldwide.

 

 

Job Description

We're hiring a Senior Quality Engineer to work onsite at our Tyrone, PA manufacturing facility. The Tyrone location produces a portfolio of products including specialty pharmaceutical, food grade nutraceuticals, performance chemicals, agricultural chemicals, and refinery catalysts.

 

As the Senior Quality Engineer, you will report to the Quality Assurance Manager and be responsible for carrying out Manufacturing Quality Assurance functions within the plant. This includes resolution of deviations, performance of product impact analysis and corrective and preventive action for events, leading and participating in investigations, approval of standard operating procedures, quality improvement programs, risk management, and assurance of cGMP and compliance. You will be an integral member of the Quality Operations team and provide support to site leadership and customers. 

 

In addition, you will be the primary backup for the Plant Quality Assurance Manager, be a leader and mentor to junior staff members, and share industry best practices for implementing and maintaining an effective Quality Management System. You will also be responsible for driving process improvements and innovation opportunities.

Responsibilities Develops product quality plans, documents, and systems by creating product specifications, quality controls, quality plans, risk analyses and FMEA’s. Develops and implements statistical quality programs and process monitoring systems. Support achievement of quality goals and Key Performance Indicators. Assess compliance of practices and procedures with company policies and applicable regulations for the Quality areas under his/her responsibility. Ensures investigations of plant events are completed thoroughly and documented accurately and are included in the plant CAPA system. Performs product impact analyses for plant events and segregates where appropriate. Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Participates on Process teams as the Manufacturing Quality Assurance function. Functions may include leading/supporting process validation, equipment qualifications, and other applicable production and process controls. Approves standard operating procedures; ensures procedures comply with policy and make sense. Conducts auditing of manufacturing documentation and quality records (calibration, validation, environmental controls, training, etc.). Member of the Internal audit team. Performs batch release. Support customer and regulatory audits/inspections. Required Qualifications B.S. degree, preferably in Biology, Chemistry or Engineering discipline. 5+ years’ experience in a regulated industry in capacity of Manufacturing, Quality, or Engineering. Knowledge of quality or compliance management such as regulations and standards affecting pharmaceutical manufacturing, including ISO 9001. Experience leading project teams across multiple functions and levels and managing competing priorities. Experience with risk management tools and techniques. Strong verbal and written communication skills. Effective problem solving and analytical skills. Strong interpersonal relations / communications skills. Physical Requirements and Environment Must be willing to wear PPE (Personal Protective equipment) including but not limited to hard hat, protective eyewear, steel-toed boots, hearing protection, Level A suit, full face respirator Must be able to stand, walk, sit, climb, balance, stoop, kneel, crouch, crawl, and climb stairs and ladders over 100 ft. Preferred Qualifications In-depth knowledge of regulations; 21 CFR  210 /211, 117, 820, ICH Q7. ASQ certification (CQE or CQA). Lean Six Sigma training with Green or Black Belt certification. Expertise in quality management tools. Auditing experience.

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Benefits Medical, Dental, Vision Insurance Life Insurance and Disability Grace Wellness Program Flexible Workplace Retirement Plans  401(k) Company Match  Paid Vacation and Holidays Parental Leave (salaried only) Tuition Reimbursement

 

 

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.