- Job Title
- Validation Engineer
- Germantown, WI 53022
- Other Location
Summary of RoleThe Validation Engineer is accountable for driving results in a fast-paced environment by executing the Site’s Validation Program supporting the introduction of new systems, or modification of existing systems such as equipment, critical utilities, facilities, process and computer systems used to manufacture APIs. The position is also responsible for periodic equipment reviews and CTC mappings throughout the asset life cycle. The Validation Engineer will establish validation protocols and procedures ensuring compliance with global regulations and company standards. The position requires execution of the Sterling Values and non-negotiables, as well as expertise in functional competencies included in this position profile.
- Provides validation support for the introduction of new equipment or modification of equipment used to manufacture new APIs.
- Assists with the development of such documents as: Validation Master Plans (VMP), Computerized System Validation (CSV), System Design Specifications (SDS), Users Requirements Specifications (URS), and Detailed Design Specifications (DDS).
- Designs validation test plans.
- Authors, executes and follows up closure documentation for FAT, SAT, Installation (IQ) Operational (OQ) and Performance Qualifications (PQ).
- Performs review, authors and revisions of Standard Operating Procedures (SOPs) and related manufacturing process documentation.
- Prepares summary reports, deficiency/discrepancy reports, gap analysis, risk analysis, failure mode & effect analysis (FMEA), traceability matrices.
- Author or Review, Approve Periodic Reviews for manufacturing equipment to evaluate the validated state of the equipment.
- Reviews and approves Mapping/(Re) Qualification of Controlled Temperature Units such as Dryers, Ovens, Freezers and Warehouses.
- Ensures that the systems associated with manufacturing process remain in a validated state by reviewing the changes made throughout their validation life cycle.
- Performs deviation investigations, and executes duties related to the documentation and follow up to Corrective Preventative Action (CAPA) plans and Change Controls (CC).
- Responsible for creating validation project and validation progress metrics /KPIs
- Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
- An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.
- Good understanding and application of GMP and regulatory requirements.
- Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans.
- Excellent communication / interpersonal skills
- Ability to read, analyze and interpret general periodicals, professional journals, internal procedures and governmental regulations.
- Ability to write reports, business correspondence and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
- Ability to perform basic math functions, compute ratios, rate, and percent.
- Ability to draw and interpret graphs and charts.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
- Ability to work with people at all levels of the organization.
- Knowledge of computers and PC’s, including Microsoft Outlook, Excel and Word.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
- Duties, responsibilities, and activities may change at any time with or without notice.
- Bachelor’s degree in Engineering (Mechanical or Chemical preferred) with coursework in Quality, Chemistry, or related field and a minimum of 4-years of experience in the Commissioning & Qualification / Validation of processing equipment, facilities, process, computer systems, critical and support utility systems used for manufacturing small molecule Active Pharmaceutical Ingredients, drug substances or pharmaceutical products.
- Experience in HVAC validation and in the design, execution and closing of validation protocols beneficial.
- Previous experience with validation of process control systems and trained in Good Manufacturing Procedures (GMP), Good Laboratory Procedures (GLP), and Good Automated Manufacturing Practices (GAMP) highly desirable.
- Knowledge in Lean Six Sigma and statistical analysis beneficial.
- This position is not eligible for a flexible schedule.
- This position is not eligible for remote / hybrid work location.
Physical Demands and Work Environment
The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level is moderate to noisy. Occasionally, employee may be exposed to airborne particles and fumes. Occasionally, employee may be exposed to chemicals. Must have the ability to wear PPE as required. Employee occasionally may be exposed to moving mechanical parts and vibration.
Diversity and Inclusion
Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.