Equipment validation engineer / filtration devices / pharma manufacturing - united states, mahmud-e eraqi

our client, a world leading pharmaceutical company in andover, ma is currently looking for an equipment validation engineer / filtration devices / pharma manufacturing to join their expanding team.

· job title: equipment validation engineer / filtration devices / pharma manufacturing

· duration: 12 months contract, extendable up to 36 months

· location: andover, ma

note:

· client has the right-to-hire you as a permanent employee at any time during or after the end of contract.

· you may participate in the company group medical insurance plan

job description:

· the instrument validation specialist will support a diverse variety of quality control and manufacturing instrumentation. this role is specific to validation of filter integrity testers for manufacturing. this role will also provide technical support for continuous improvement projects, including data integrity initiatives, driving the projects to completion to support the ongoing activities within the laboratory and manufacturing environments.

· this position will provide support for the validation program and validation projects at the client andover site.

· proficient in instrument validation, writing validation plan, requirement specification and protocols. candidate must have experience in executing instrument validation protocol to ensure data integrity.

· ample knowledge in computer system validation and good understanding of electronic records and electronic signature.

· good technical writing skills and familiarity with validation deviation.

· work with operations, quality, technical groups, and other site/network groups as required assisting with establishing business and compliance requirements of instrumentation and processes.

· plan and coordinate the validation/qualification work assigned, including validation plans, validation strategy, requirements specifications, qualification protocols, and impact / risk assessments.

· providing technical support and participating in the implementation of change controls and commitment action items

· providing technical support and supporting ongoing investigations

· familiarity with decommissioning of instruments

· technical understanding of process and instrumentation to be qualified

· skilled at the use of enterprise systems including, but not limited to site quality tracking system (qts), laboratory information management system (lims), empower and/or chromatographic applications and pharmaceutical document repositories

· applying technical and quality concepts, applicable guidelines of the fda or other regulatory bodies and relevant sops.

· role will be expected to work monday – friday standard shift. weekends or off hours may be required as needed. this role will be fully onsite.

·         this position will regularly interact with quality control, quality assurance, andover production operations, engineering validation and maintenance, site technical services, third party vendors and business technology as well as others as applicable.

notes:

·         looking for someone to jump right in with validation activities supporting manufacturing and development operating in regulated environment.

·         should be able to follow all policies and procedures in a regulated environment.

·         100% onsite. must follow return to site policy

·         m-f 1st shift, some off hour or weekend work may be needed but would need to adjust other hours to stay within 40.

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