Pfizer Validation Specialist Day Shift in Andover, Massachusetts

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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

• Performs all work in compliance with current Good Manufacturing Practices (cGMP) and site requirements.

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

• 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).

• Determines workflow for new instruments; Provides lab support for instrumentation qualification;

• Serve as a System Admin to QC applicable software (e.g., Empower, Omnic, Lab-X, UV WinLab,etc).

• Coordinate QC instruments Service Agreement and serve as a liason with Purchasing Department and QC.

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

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

• Initiate, execute, and track Commitments and Corrective Action/Preventive Action (CAPA) as needed.

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

• Trains less experienced analysts in new and existing procedures, techniques and governmental regulations. Mentors analysts by 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 GMP\compliant manner.

• Carries out technical and administrative duties as needed.

• BS in scientific discipline (e.g., Chemistry or Biology) or related field with 5-8 years or MS in Chemistry or Biology or related field with 3-5 years of industry experience, preferably in the pharmaceutical or biopharmaceutical industry.

• Extensive knowledge and practical application of relevant techniques - working with variety of 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 independently 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 Enterprise Systems (e.g.,Labware LIMS, Empower, QTS, PDOCS)

• cGMP experience is required.

• Candidate must be detail 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, Excel and Powerpoint are required).

• Familiarity with other laboratory applications (e.g., SoftMax pro, ImageLab, UV Probe, UV WinLab, Image Lab, etc.) is a plus.

PHYSICAL/MENTAL REQUIREMENTS

Position is a mixture of laboratory 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.

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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

• Performs all work in compliance with current Good Manufacturing Practices (cGMP) and site requirements.

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

• 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).

• Determines workflow for new instruments; Provides lab support for instrumentation qualification;

• Serve as a System Admin to QC applicable software (e.g., Empower, Omnic, Lab-X, UV WinLab,etc).

• Coordinate QC instruments Service Agreement and serve as a liason with Purchasing Department and QC.

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

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

• Initiate, execute, and track Commitments and Corrective Action/Preventive Action (CAPA) as needed.

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

• Trains less experienced analysts in new and existing procedures, techniques and governmental regulations. Mentors analysts by 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 GMP\compliant manner.

• Carries out technical and administrative duties as needed.

• BS in scientific discipline (e.g., Chemistry or Biology) or related field with 5-8 years or MS in Chemistry or Biology or related field with 3-5 years of industry experience, preferably in the pharmaceutical or biopharmaceutical industry.

• Extensive knowledge and practical application of relevant techniques - working with variety of 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 independently 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 Enterprise Systems (e.g.,Labware LIMS, Empower, QTS, PDOCS)

• cGMP experience is required.

• Candidate must be detail 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, Excel and Powerpoint are required).

• Familiarity with other laboratory applications (e.g., SoftMax pro, ImageLab, UV Probe, UV WinLab, Image Lab, etc.) is a plus.

PHYSICAL/MENTAL REQUIREMENTS

Position is a mixture of laboratory 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.

EEO Statement

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.

Additional Offer Details:

  • Grade: 7

  • Additional Location Information : Andover, MA

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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