Validation Specialist

Operations Seymour, Indiana


Description

Job Summary – a concise overview of the job

Responsible for supporting equipment qualification and process validation programs including creation and execution of protocols (including sampling and process monitoring) as well as writing/routing/obtaining approval of final reports.  The specialist is expected to work cooperatively with Regulatory Affairs, Operations, Quality Assurance, Research & Development and Product Compliance.

Scope of Job -- size of organization, P&L responsibility, budget responsibility

Coordinate/route documentation, generate some documents. 

No P&L or budget responsibility

 

 

Key Accountabilities – essential duties/responsibilities

Accountability

Responsibilities

% of Time

Generating TS Documents

  • Create and coordinate approval of equipment qualification protocols and reports in line with established validation policies and procedures.
  • Create and coordinate the approval of process validation protocols and summary reports in line with established validation policies and procedures.
  • Create and coordinate approval of cleaning validation protocols/reports and associated documentation in line with established validation policies and procedures
  • Create and coordinate the approval of continued process validation verification plans/reports in line with established validation policies and procedures.
  • Assure validation documentation is available for operation activities.

60%

Other

  • Responsible for assisting in the validation impact assessment regarding changes to validated systems and processes.
  • Troubleshoot/investigate validation-related issues.
  • Maintain completed validation and qualification packages.
  • Execute or assist execution of approved validation and qualification protocols, requiring product monitoring and sampling and also communicating activities.
  • Attend meetings as required to ensure validation activities are tracking to project schedules.

40%

Total Accountabilities

 

100%

 

 

 

 

Qualifications

 

 

Scope of Decision-Making:  (Check only one box to indicate the applicable level of decision-making responsibility required for this position, without any procedures/instructions to follow.)

 

    Decisions require little judgment. Understand and follow basic/routine instructions and use basic/routine equipment involving few decisions.  Duties are extremely standardized and performed under direction supervision or review.

 

    Decisions require some judgment.  Perform repetitive or routine duties working from detailed instructions and under standard procedures. Requires making minor decisions.

 

   Decisions require basic/routine analytical judgment.  Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures.  Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

 

X    Decisions require complex analytical judgment.  Plan and perform a wide variety of duties requiring general knowledge of company policies and procedures applicable within area of responsibilities, and including their application to cases not routinely covered.  Requires considerable judgment to work independently toward general results, devise methods, modify or adapt standard procedures to meet different conditions, make decisions based on precedent and company policies.

 

 

Level of Supervision Provided:  (Check only one box to indicate the applicable level of supervision for which this position is responsible.)

 

 

    Individual contributor, not responsible for the work of others.

 

 

    Project direction of other employees performing the same or directly related work.

 

 

X    Project direction of other employees performing the same or directly related work, including assigning, reviewing, checking work, eliminating ordinary supervisory/management positions.

 

 

    Direct supervision responsibility, including performance assessments, of 1 – 10 employees.

 

 

    Direct supervision responsibility, including performance assessments, of more than 10 employees.

 

Internal/External Contacts:  (Check only one box to indicate the applicable level of internal and/or external contacts required for this position.)

 

    Primarily within department or immediate work unit:  Requires contacts within the department or functional area on routine matters, or contacts with other departments.  Occasionally contacts individuals outside the organization.  Contacts are primarily for the purpose of supplying or seeking information.

 

X    Regular inside and outside the organization:  Requires regular contact with subordinates and/or other departments, with occasional contacts with individuals outside the organization.  Also includes jobs with regular customer/client contacts.

 

    Regular inside and outside:  Requires contacts to carry out company policy and programs.  Improper handling will have considerable effect on operating results. Must often deal with persons of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.

 

    

 

Required

Preferred

  X  High School Diploma / GED

    High School Diploma / GED

    Associate’s Degree

 X   Associate’s Degree

 X   Bachelor’s Degree

    Bachelor’s Degree

    Master’s Degree or        Ph.D.

 X   Master’s Degree or  X   Ph.D.

    Other

    Other

Experience

(Industry and Years)

Work experience (type of industry and years of experience) and certifications required for the job

  • 5+ years' experience performing equipment/facilities qualification and/or Process Validation within the Pharmaceutical industry.
  • Working knowledge of various manufacturing process including those used granulation, drying, sizing, blending, compression, encapsulation, coating, printing, and laser drilling.
  • Knowledge of current applicable regulatory standards (FDA, CFR, ICH etc.)
  • Experience in data analysis, technical report writing, root cause analysis, and risk assessment.

 

Specific Skills

List any additional specific skills and knowledge necessary to meet the objectives of the position; including any specialized software or equipment regularly utilized in the performance of the job, analytical skills, management or leadership skills, etc.

  • Strong initiative and integrity as well as strong written and verbal communication skills
  • Proficiency with Microsoft Office suite preferred.
  • Proficiency with MiniTab, SAS, or other statistical data processing software preferred.
  • Ability to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is requireds
  • Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills preferred.

Physical Requirements

List the details of the environment within/under which work is performed and physical requirements for this position, e.g., lift 50 pounds, walk across plant/warehouse, business travel (% of time).

  • Traditional office environment, with frequent walking to other areas of the facility, including production areas, loading docks, mechanical spaces and warehouse.