Sr. Engineer, Validation and Automation
The Sr. Engineer, Validation and Automation is responsible for the coordination and execution of all technical activities on assigned validation projects. This role plans, schedules, conducts, and coordinates assigned validation work, monitors work for compliance to applicable codes/regulations (e.g., cGMP), accepted engineering practices, and Par standards, and ensures effective communication and coordination on assigned projects between all disciplines and all other project participants. This position is also responsible for managing the automation portion of production equipment from design, specification, procurement, validation, and defending to agencies (e.g., FDA, EMEA, JTI) for compliance.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Engineering Services Operating unit for Irvine Generics Operations and Manufacturing site.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Writes and executes Validation Protocols such as Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Standard Operating Procedures (SOP) writing and review, and data review of executed validation studies, writing of final reports.
§ Supports installation of pharmaceutical production equipment.
§ Perform Factory Acceptance Testing (FATs) on new/used pharmaceutical equipment.
§ Executes facility and equipment validation projects.
§ Executes protocol testing and generates related final reports.
§ Interfaces with R/D Technical Service Group and Production during facility/equipment validation activities.
§ Supports equipment Qualification/Validation efforts.
§ Responsible for the coordination and monitoring of engineering deliverables on automation projects.
§ Seeks new technologies and automation opportunities in lowering the overall cost of manufacturing.
§ Maintains automation systems including username/password maintenance, PLC backups.
§ Complies with cGMP, safety requirements, and company policies.
§ Performs other duties as assigned.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor’s degree in Chemical, Mechanical, or Electrical Engineering or related studies; may be substituted with demonstrated success in pharmaceutical equipment installation/validation and automation execution.
§ Minimum of 5 years’ experience with controls and instrumentation in the Pharmaceutical field.
§ Experience with analyzing mechanical, electrical, and pneumatic drawings.
§ Hands-on experience working with industrial automation such as PLC, VFD, etc.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Demonstrated knowledge of FDA, cGMP regulations and guidelines, especially 21CFR Parts 11, 210 and 211.
§ Demonstrated computer proficiency: Microsoft Suite and AutoCAD.
§ Knowledge of how equipment is used in pharmaceutical plant operations and the typical measurements which are critical to operation.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Ability to engage trades people and effectively build relationships to drive performance.
§ Ability to work independently, efficiently, and effectively.
§ Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
§ Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
§ Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
§ Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
§ Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
§ Ability to handle multiple projects and assignments; Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
§ Manages difficult or emotional customer situations; Responds promptly to customer needs; Solicits customer feedback to improve service; Responds to requests for service and assistance; Meets commitments.
§ Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
§ Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.
§ Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Occasionally be required to stand, walk, sit, climb ladders, reach with hands and arms, climb or balance, stoop or kneel, talk and hear, and use fingers and hands to feel objects, tools or controls.
§ Specific vision abilities required include close vision, distance vision, depth perceptions, and the ability to adjust focus.
§ Overtime may be necessary as work load’s dictate. This may include weekdays, weekends and/or holidays.
§ Regularly lift and /or move up to 10 pounds and occasionally lift and/or move up to 45 pounds.
§ Climb ladders and ship ladders and work in high, precarious places up to elevations of 75 feet.
§ Regularly exposed to work near moving mechanical parts.
§ Exposed to wet or humid conditions.
§ Work in a dusty environment that will require the use of respirator.
§ Exposed to outdoor weather conditions.
§ Regularly exposed to high noise environments that will require the use of hearing protection (ear plugs).
§ Exposed to chemicals used in the manufacturing process.
§ Extended periods of standing.
§ Required working on floor and in tight spaces to obtain nameplate information.
§ Job will generally be performed in an office environment, but may require work in a production facility or industrial/construction job site. Conditions will vary at each location, but the conditions listed above will generally apply.