Engineer II, Validation

Location

Middletown, OH | United States

Job description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company’s Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement – eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Middletown, VA

Shift: First

Responsible for validation work for projects, as well as participation as an interactive member on Project Teams as a representative of the validation department. Writes and completes commissioning and validation documents for Pharmaceutical Manufacturing Equipment and Systems in accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and validation summary reports. Participation on various project teams will be required!

A day in the Life:

• Develop commissioning and qualification lifecycle documentation.
• Author and/or revise SOPs as necessary.
• Advise functional departments on the creation of user and system specifications and requirements, as well as reviewing/approving these documents.
• Responsible for protocol execution requiring interface and coordination with Validation personnel, Manufacturing, QA, QC, Facilities, Metrology and Engineering departments to assure expeditious and accurate completion per agreed upon project plan.
• Summarize and evaluate protocol data, including resolution of discrepancies and exceptions as required for completion of validation summary reports.
• Perform periodic reviews or re-qualifications to maintain validation status of equipment, instruments, facilities, utilities, and computer systems as defined by approved validation SOPs.

Education

Bachelor of Science in Engineering field (Chemical, or related)

Experience

2+ years in validation experience in manufacturing.

Equivalency

Equivalent combinations of education, training, and relevant work experience may be considered.

Knowledge, Skills, Abilities

• Must be proficient on validation protocol development, technical writing, data analysis, and report generation. i.e.; IQ, OQ, PQ, FAT, SAT as an example.
• Strong technical writing skills, accuracy, attention to detail, and technical knowledge.
• Must be proficient in statistical analysis and process control.
• Must have knowledge of process + packaging equipment.
• Knowledge of global regulatory and quality requirements associated with medical devices.
• Excellent communication skills and an ability to effectively collaborate with others to achieve team goals and expectations.
• Self-starter with an ability to work in a fast-paced environment and to effectively manage time and prioritize work.
• Experience with pharmaceutical manufacturing equipment and processes
• Basic understanding of GMPs
• Excellent computer skills (Microsoft Word, Excel, Project, Power Point, etc.)

Job tags

Salary