Senior Manager, Validation in Albuquerque, NM

Job Snapshot

Job Description

Description

Summary: The Validation Senior Manager will work with other departments to make sure the risk assessment, IQ, OQ and PQ activities associated with new components, equipment (including laboratory testing equipment), systems, and utilities are performed according to established schedules, user requirements and needs.  This position is also responsible for managing the activities of the Validation Department during facility shutdown activities and ensuring the plant is in a ready state to manufacture
Essential Duties and Responsibilities:
• Responsible for providing leadership to the employees within the Validation Department.  Performs duties of a manager such as developing annual goals and objectives for department, developing, implementing and managing annual operating budget, approving expenditures, monitoring staffing, addressing employment issues, ensuring compliance with regulations and policies, and managing the overall functions of the Validation Department.
• Reviews and approves Validation Master Plans related to cleaning, facilities, packaging systems, and computer-related systems for the facility.
• Reviews and approves qualification, validation, re-qualification, and re-validation documents for equipment and systems, as well as manufacturing process protocols and final reports.
• Provides validation assessments for facility, utility, and equipment changes as well as input related to product technology transfers to the facility.
• Coordinates validation activities with section supervisors to ensure timeliness with minimal disruption to production schedules.
• Serves as the Validation liaison between the site and customers or regulatory agencies during facility audits/inspections.
• Develops and supports departmental strategic goals to assure the highest quality standards and regulatory compliance. 
• Ensures records, and procedures are in compliance with current Good Manufacturing Practices (cGMP).
Supervisory Responsibilities:
Directly supervises six employees in the Validations Department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Education and/or Experience:
Bachelor’s Degree in Engineering, Life Sciences or Computer Science with 6+ years of experience in pharmaceutical validation (aseptic/sterile product facility), or equivalent experience.  BS degree in a scientific discipline with at least 6 years of experience, or MS degree with at least 4 years of related experience.
Language Skills:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or 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.
Mathematical Skills:
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability:
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Computer Skills:
Proficient in the use of MS Word, Excel, Outlook and Access Other Skills and Abilities:

• Excellent Communication skills, both verbal and written
• Ability to organize time in order to successfully manage multiple projects and priorities
• Ability to read, understand, interpret and implement technical writing and instructions.
• Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
• Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
Other Qualifications: Must pass background check Must pass drug screen
Physical Demands: While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance 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 and depth perception.
Work Environment: While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.
All interested applicants must apply online.  AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Note This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

Qualifications

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Job: Quality
Primary Location: Albuquerque, NM
Schedule: Full time
Shift Type:

AMRI is an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

If you'd like to view a copy of the company's affirmative action plan or policy statement, please email jobs@amriglobal.com. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please email jobs@amriglobal.com. This email is created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

EEO is the Law (English / Español) / EEO Supplement / Pay Transparency

E-Verify: United States Employment Opportunities Only
E-Verify is an internet-based system operated by the Department of Homeland Security and the Social Security Administration and allows employers to confirm an individual’s employment eligibility to work in the United States. Under the E-Verify rules, effective September 8, 2009, federal agencies subject to the Federal Acquisition Regulation are required to modify, and include in new contracts, a provision that requires federal contractors and subcontractors to use E-Verify. As a federal contractor, AMRI is required to adhere to these requirements. Effective June 2008, AMRI began processing all new hires through E-Verify in all states.

Important E-Verify Information
Please read the attached notices, available in English and Spanish, for important information.

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