Validation Engineer - BioPharm at Man...
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Jul
28
Sandeep Singh Dhillon
Validation Engineer – BioPharm at Mangan Inc Cambridge, MA 02238 – Monster.com
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Company Description
Mangan Biopharm is a subsidiary division of Mangan Inc. and is a full service Engineering and Life Science Quality and Compliance Company. Mangan has over 25 years of experience in Engineering, Procurement and Construction with 15+ years of experience in Lifesciences Engineering and Compliance Consulting. We are customer-centric and fully committed to our clients needs and as a result, most of our business is repeat business.

Job Description

Position Summary:

The Validation Engineer is responsible for execution of validation projects for equipment, facilities, and utilities in a pharmaceutical manufacturing, packaging, or support environment. The candidate must be able to work independently, but be able to coordinate execution efforts with operations, manufacturing, facilities, laboratories, development, materials management and quality assurance personnel. This role will play an integral part in overall project success.

Duties:

Validation Engineer I ( 2 – 5 years of Experience/Salary range $60 to $80k)

 Reviews validation packets for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis. Compares results against acceptance criteria and bring exceptions and deviations to management’s attention

 Maintains appropriate validation documentation and files in accordance with regulatory requirements and internal procedures

 Effectively apply validation methodology and standards

 Support, investigate and troubleshoot problems and determine solutions

 Provide technical assistance during investigations of process /equipment / cleaning / validation issues. Generate and resolve validation deviations / protocol discrepancies

Validation Engineer II ( 5 – 9 years of Experience/Salary range $80 to $100k)

 Analyze validation data, prepare summary reports and provide recommendations for improvement in manufacturing process and equipment

 Develop training packages, JSAs and writing Best Known Methods (BKM) for Validation

 Serve as a dependable liaison between validation and manufacturing

 Identify, respond to and monitor potential project risks and determine possible contingency plans for risk mitigation

 Reviews technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, Technical Manuals, P&IDs, construction, as-built, flow diagrams as they relate to validation principles and regulatory compliance issues

Qualifications:

 Bachelor’s degree in engineering, science or related field

 Excellent organization and time management skills

 Good understanding of cGMP validation requirements / guidelines and current industry practices

 Results-oriented, able to make decisions, and able to prioritize validation project and client needs

 Strong teamwork and collaboration

 Must have excellent interpersonal, technical writing and communication skills

 Proficient in use of MS Office software suite

 Ability to work occasional off shift and/or weekends to accommodate schedules and/or project timelines

Apply at http://job-openings.monster.com/Validation-Engineer-BioPharm-Cambridge-MA-US-Mangan-Inc/11/186239493?JDNJobDocument.JobID=132549024&AdID=28361036&ImpressionGuid=fdaae5cd-6b40-2429-c1c6-3566f228ad51&AffiliateGuid=63315516-d696-4397-af9e-806bf6170167&CampaignID=240301&Premium=0&RendererID=2146&code=-1&unit=-1&stracking=&WT.mc_n=JDN000003



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