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Instruments Validation Specialist


Andover, MA
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Job Details

The qualified candidate must have the experience and ability to participate in multiple projects within Quality Control. She/He will participate and perform a variety of instrument validation activities to maintain the validated life cycle of QC laboratory instruments (e.g., validation of new instrument, revalidation of legacy instruments, performance verification, calibration, software and hardware through change control, periodic reviews, decommissioning, application support, schedule annual PMs, renewal of instrument service agreements).


Performs all work in compliance with cGMPs and site requirements.

Perform QC instrument validation activities (e.g., validation of new and legacy instruments, HPLC performance verification, calibration, periodic reviews, decommissioning, Empower and laboratory application support).

Prepare laboratory reagents for use in instrument performance verification/calibration.

Write and/or revise standard operating procedures for laboratory instrumentation and maintenance.

Write and/or revise computer related system validation documents (e.g., validation plan, test plan, requirements specification, qualification protocol, and validation summary reports).

+ Participate in Business Technology (BT) initiatives as applicable (e.g., firmware and software upgrade, serve as liason between QC labs and BT).

+ Participate in continuous improvement Program/OE initiatives.

+ Initiate, execute, track Change Controls as needed per lab requirements.

+ Contribute to Continuous Improvement initiatives through M1 and other available toolkits (identify opportunities, collaborate with cross-functional team and implement/measure) .

+ Participate in providing technical knowledge and support in resolving technical problems.

+ Oversees maintenance of all related records, and ensures that work area is maintained in a neat, safe, orderly, and compliant manner. Suggests continuous improvements to systems, procedures, etc. Carries out technical and administrative duties as needed.

**Qualifications: Education and Experience**

BS in scientific discipline (e.g., Chemistry or Biology) or related field with 2-5 years or MS in Chemistry or Biology or related field with 1-5 years of industry experience, preferably in the pharmaceutical or biopharmaceutical industry.

Extensive knowledge and practical application of relevant analytical techniques is a plus- working with variety of QC laboratory analytical instrumentation [e.g., High Performance Liquid Chromatography, Gas Chromatography, variety of Spectrophotometers (UV-Vis, NIR, AAS, ICP, Plate Readers), Capillary Electrophoresis, imaging Capillary Electrophoresis, and others)].

Demonstrated ability to develop, document, validate, and troubleshoot laboratory instruments of high levels of complexity.

+ Familiarity with predicate rule, FDA, MHRA & WHO guidance documents required. 21CFR part 11.

Proficiency with MS Word and Excel

cGMP experience is required.

Candidate must be detailed oriented with strong verbal and written communication skills (e.g., technical writing skills, validation documents and etc.).

Ability to work well in a team environment.

Strong independent work skills to meet established deliverables (project management experience is a plus)

Computer skills in MS Office (Word, Powerpoint and Excel are required).

Familiarity with Empower, QTS, LabWare LIMS and other laboratory applications (e.g., SoftMax pro, ImageLab, UV Probe, UV WinLab) is a plus.

**Technical Skills:**

Working knowledge of analytical techniques such as chromatographic separation application, and variety of spectrophotometry (e.g., UV-Vis, ICP, NIR, FTIR, etc).

Strong understanding of instrument validation and scientific methodology in order to plan studies, interpret results, and draw conclusions

Plans and prioritizes concurrent assignments/activities.

Highly motivated individual who receives minimal supervision on routine assignments.

+ Demonstrates flexibility and ability to multi-task.

+ Capability and desire to work as a team member in a fast paced environment. \\

+ High level of communication skills with peers and management. Understands the theory behind the techniques ("hows" and "whys" of what he/she performs) or is willing to learn. Detail oriented; able to compile data in a clear and understandable format and notice discrepancies, calculation errors, and deviations from test methods and/or acceptance criteria and support data review **Physical Requirements:** Position is a mixture of lab and office, approximately 50% of the time will be spent in the laboratory. Laboratory duties such as instrument installation, qualification, calibration and maintenance may be required.

+ This job is Pfizer U.S. Exempt Grade 04

**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

+ **Last Date to Apply for Job:** January 17, 2018.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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