Responsibilities
Technical Expertise
• Possesses strong knowledge of validation and related practices, including governmental regulations. Developing broader skills and applies this knowledge and skills to perform a variety of standard activities.
• Demonstrated success in technical proficiency, creativity, and collaboration with others and independent thought
• Develops/execute and review validation test plans & protocols consistent with site procedures and practices
• Reviews and approve validation related system lifecycle design documentation (user requirements, functional and design specifications, commissioning and qualification protocols)
• Perform equipment, aseptic processing, steam sterilization, cleaning validation and process validation and their associated control systems
• Manages validation activities within timeline commitments including developing a plan with timeline, deliverables, and accountabilities
• Represents validation on projects and in addressing issues. Develop and recommend solutions outside general practices with a focus on continuous improvement and compliance.
• Develop systems that promote and result in improved efficiency within the department and company.
• Summarize major project validation activities in reports.
• Represents validation on internal teams, committees and at technical conferences
Problem Solving
• Provide an engineering-based validation review and input for CAPAs and Deviations.
• Solves a range of varied and complex problems requiring analysis/interpretation and are solved using knowledge/skills, precedents and practices. These include but not limited to process troubleshooting, operations support, root cause analysis, and risk assessment to document and accept risk.
• Exercising judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
• Determine methods and procedures on new moderately complex assignments and implement them after obtaining necessary stakeholder approvals.
• Determining methods and procedures on new complex assignments, and providing technical direction to other engineers within the Validation department
• Demonstrate strong leadership and management qualities when working within the department and other stakeholder groups that yield results.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
Requirements
• BS Engineering/Chemistry/Microbiology or related field
• Minimum 8 years related industrial experience in the area of system qualification or validation
• Expert knowledge of validation principles and concepts
• Basic skills and fluency in Microsoft Word and Excel
Skills
• Possesses strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, CFR 210, 211, Part 11, BPE.
• Reputation as emerging leader in field with sustained performance and accomplishment
• Experience with systems such as Controlled Temperature units, Critical Utilities, Facilities, Equipment systems, Computer or Controls Systems preferably used in a GLP or GMP environment
• Strong communication and computer skills
• Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought.
• Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Ensure alignment and communication of issues and strategies.
Physical/Mental Requirements
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, lift/carry 25lbs, pull 50lbs Use phone, fax, copier, computer, copier, hand tools. Noise above conversation level, hot/cold temperatures, high humidity, and restricted access laboratory, exposure to animals, animal areas, or equipment used in animal area environment. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, prepare transaction documents.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
