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Job Details
Work Location: Jaffrey, New Hampshire
Shift: No
Department: LS-SC-PEJBHB Raw material and equipment validation (1208071)
Recruiter: Ashley Hennessy
This information is for internals only. Please do not share outside of the organization.
NOTICE OF FILING
This notice is posted as the result of the filing of an Application for Alien Labor Certification with the Department of Labor for the job opportunity listed below. Any person may provide documentary evidence bearing on this Labor Certification Application to Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.
Employer: EMD Millipore Corporation
Employer Address: 400 Summit Drive, Burlington, Massachusetts 01803
Worksite Address: 11 Prescott Road, Jaffrey, New Hampshire 03452
Job Title: Validation Engineers II
Job Duties: (1) Design and Lead intermediate to complex level equipment, and process validations activities; (2) Lead investigations on validation protocol discrepancies to identify the root causes; (3) Lead change requests in Change Management system, ensuring implementation solutions, support operational needs and meet quality standards; (4) Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification; (5) Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials; (6) Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated state; (7) Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements; (8) Prepare, maintain, and review Validation documentation for DQ, FAT, IQ, OQ, PQ, and process qualification; (9) Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment; and (10) Consult with management and assess customer requirements to select validation objectives and standards.
Salary: One hundred three thousand to one hundred twenty-three thousand dollars per year.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
Travel: 10% domestic travel and 5% international travel is required.
Requirements: Employer requires a bachelor's degree in engineering, computer science, or a closely related STEM field, and two (2) years of work experience as a Validation Engineer, or related occupation, providing computer and equipment validation lifecycle experience. In addition, employer requires: (1) Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in a startup Biotechnology industry gained through two (2) years of work experience; (2) Demonstrated knowledge of FDA 21 CFR Part 11 regulations gained through one (1) year of work experience; (3) Demonstrated knowledge of temperature mapping of controlled temperature units gained through one (1) year of work experience; and (4) Demonstrated ability performing Root Cause Analysis with robust Corrective and Preventive Actions in Life Science industry gained through one (1) year of work experience. All years of experience may be gained concurrently.
Applicants can mail resumes to EMD Millipore Corporation., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 291354 or apply online at ;br>
DATE POSTED: DATE REMOVED:
LOCATION POSTED:
EMPLOYER SIGNATURE:
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Shift: No
Department: LS-SC-PEJBHB Raw material and equipment validation (1208071)
Recruiter: Ashley Hennessy
This information is for internals only. Please do not share outside of the organization.
NOTICE OF FILING
This notice is posted as the result of the filing of an Application for Alien Labor Certification with the Department of Labor for the job opportunity listed below. Any person may provide documentary evidence bearing on this Labor Certification Application to Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue NW, Room N-5311, Washington, DC 20210.
Employer: EMD Millipore Corporation
Employer Address: 400 Summit Drive, Burlington, Massachusetts 01803
Worksite Address: 11 Prescott Road, Jaffrey, New Hampshire 03452
Job Title: Validation Engineers II
Job Duties: (1) Design and Lead intermediate to complex level equipment, and process validations activities; (2) Lead investigations on validation protocol discrepancies to identify the root causes; (3) Lead change requests in Change Management system, ensuring implementation solutions, support operational needs and meet quality standards; (4) Execute Quality System elements like CAPAs, Change Controls, Deviations and Investigations resulting from equipment, utilities, and raw materials qualification; (5) Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and raw materials; (6) Perform Validation program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated state; (7) Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design meets manufacturer's specification and functional requirements; (8) Prepare, maintain, and review Validation documentation for DQ, FAT, IQ, OQ, PQ, and process qualification; (9) Perform assessment of vendor change notifications to identify the impact of the change on validated status of equipment; and (10) Consult with management and assess customer requirements to select validation objectives and standards.
Salary: One hundred three thousand to one hundred twenty-three thousand dollars per year.
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.
Travel: 10% domestic travel and 5% international travel is required.
Requirements: Employer requires a bachelor's degree in engineering, computer science, or a closely related STEM field, and two (2) years of work experience as a Validation Engineer, or related occupation, providing computer and equipment validation lifecycle experience. In addition, employer requires: (1) Demonstrated ability in releasing clean rooms for GMP production use complying to FDA regulations in a startup Biotechnology industry gained through two (2) years of work experience; (2) Demonstrated knowledge of FDA 21 CFR Part 11 regulations gained through one (1) year of work experience; (3) Demonstrated knowledge of temperature mapping of controlled temperature units gained through one (1) year of work experience; and (4) Demonstrated ability performing Root Cause Analysis with robust Corrective and Preventive Actions in Life Science industry gained through one (1) year of work experience. All years of experience may be gained concurrently.
Applicants can mail resumes to EMD Millipore Corporation., 400 Summit Drive, Burlington, Massachusetts 01803 (Attn: req# 291354 or apply online at ;br>
DATE POSTED: DATE REMOVED:
LOCATION POSTED:
EMPLOYER SIGNATURE:
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.