Specialist, Global Analytical Instrument Validation Specialist
Specialist, Global Analytical Instrument Validation Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 94300 - 148500
1 Vacancy
Job Description
Job Description
The Analytical Research & Development (AR&D) External Capabilities Validation and Compliance (ECVC) department of our companys Research Laboratories Division is seeking applicants for a Validation Specialist position available at either the Rahway New Jersey or West Point PA research facilities.
The Analytical Instrument Validation Specialist will work as part of the integrated Validation and Compliance team and drive a culture of quality and operational excellence across the global AR&D network. The Analytical Instrument Validation Specialist role oversees and supports the validation of computerized analytical instrumentation within the GMP environment for multiple USbased sites in Pennsylvania and New Jersey.
The key responsibilities of this role will include:
- Partner with scientific teams across AR&D to drive compliance and operational excellence
- Validate novel and timesensitive instrumentation in GMP environments to 21CFR11 compliance
- Support standardization activities for System Development Life Cycle globally
- Support internal and external quality audits and maintain laboratory state of permanent inspection readiness within the scope of SDLC
- Contribute to Standard Operating Procedures (SOP) drafting
- Originate and own Investigations and Change Management records
The successful candidate must function both independently and be able to collaborate in a fastpaced integrated multidisciplinary team environment. Strong communications skills and eagerness to adapt and learn are essential attributes. As a member of our team you will be joining scientific and technical problem solvers who are dedicated to creating the lifechanging medicines of tomorrow.
Education Minimum Requirements (standard for each level)
Bachelors degree or higher in analytical chemistry or related field with 3 years postdegree relevant industry experience.
Required Experience and Skills
- A strong team player with the ability to work both independently and crossfunctionally to deliver on complex objectives
- Proven track record of strong technical and innovative problem solving
- Desire and ability to learn new concepts outside of core expertise and training
- Excellent verbal and written communication skills demonstrated creativity and strong interpersonal skills
- Related industry experience with computerized equipment or instrument validation
- Experience working within a GMP environment
- Understanding of GMP policies and procedures
Preferred Experience and Skills
While not required experience in one or more of the following areas is beneficial.
- Demonstrated commitment to diversity and inclusion
- Experience with IT computerized systems software and applications including Secure Desktop
- Experience leading a team for a common goal
- Experience in Auditing and Compliance within pharmaceutical industry including change management and deviation management
- Experience supporting internal and external quality audits
- Experience in instrument computer system validation
#eligibleforERP
#AR&D
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$94300.00 $148500.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
25%Flexible Work Arrangements:
Not ApplicableShift:
1st DayValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/17/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Exec
Employment Type
Full-Time
