West Pharma Process Engineer 

United States, North Carolina 

505153708

The Process Engineer will organize, coordinate, or perform modifications, validations, and enhancements of processes, equipment, and tooling to new and existing products to ensure safety, maximum yields, quality, cost effectiveness and throughput of our processes. This role will primarily focus on the facilities high value processes surrounding pharmaceutical washing and sterilization.

Primary Duties and Responsibilities:

• Support the development and improvement of products and processes assuring the Plant’s competitive position.
• Support projects and initiatives stemming from Global Process Engineering team for High Value Products.
• Initiate, support, execute CAPA and other quality initiatives.
• Ensure compliance with cGMPs, FDA and other regulations as necessary.
• Guide, coordinate, or perform modifications, improvements, or validations of existing or new products, processes, tooling, equipment, and related research and development activity.
• Plan, schedule, or perform projects within the approved time schedules and budgets.
• Support/lead Operations Excellence lean and continuous improvement activities.
• Support new and experimental product development activities.
• Review procedures to ensure they reflect the most effective means and contain the most current and correct information.
• Maintain engineering records and documents as required.
• Lead the way in supporting the plant’s efforts in meeting corporate and plant goals.
• Review processes continually to ensure their quality.
• Safeguard confidential information.
• Maintain effective team member relations.
• Performs other duties as assigned based on business needs.
• Conforms with and abides by all regulations, policies, work procedures, instruction, and all safety rules.

Required Qualifications:

• Education: Bachelor's in Engineering or Sciences
• Must have 2-3 years of experience in Biotechnology/Pharmaceutical manufacturing.
• Must have excellent written and verbal skills.
• Excellent interpersonal skills: good team player and individual contributor as well.

Preferred Qualifications:

• Lean Six Sigma Black Belt (or Green Belt with solid track of lean improvements).
• Working knowledge of SPC and Minitab software.
• Knowledge of cGMP for aseptic/ clean room manufacturing.
• Ability of authoring/revising SOIs, SOPs and validation documents.

Physical & Travel Requirements:

• Travel up to 10%
• Office environment