Job Description
Primary Responsibilities
Directly support performance qualification activities
Collection of utility systems samples including water, clean steam, and clean dry air
Execute environmental sampling of classified areas including active viable air, non-viable air, and surface sampling
Compile and author annual reviews
Provide data entry, review, and approval as required in GLIMS
Provide summaries of test results to appropriate personnel as necessary
Compile and evaluate environmental monitoring data for adverse trends
Conduct investigations for deviations and Out of Specification results
Interprets our Company's Quality policies, GMP's and other agency regulations for application to Wilson Operations
Identifies and implements continuous improvement activities
Maintains 5S organization and identifies improvement opportunities
Demonstrates leadership by maintaining a safe workplace and identifying actions to prevent safety incidents
All other responsibilities as assigned by leadership
Education Minimum Requirements
Required Skills
Minimum two (2) years of GMP pharmaceutical industry experience
Aseptic filling, environmental monitoring and process simulations
Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry
Perform routine assignments and develop competence by performing structured work assignments
Use existing procedures to solve routine and standard problems
Promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives
Readily accepts performance feedback and incorporates this feedback into future performance
Ability to interpret our Company's Quality Policies, Procedures and Guidelines for daily application
Ability to independently reply to basic requests for data and trending of data
Willing to work irregular hours to support multi-shift operation on an as needed basis
Current schedule 8-hour day shift or as needed to support projects.
Shift schedule will change at the end of 2025 to 12-hour night shift.
Preferred Skills
Technical writing experience
GLIMS
Ability to learn new processes and computerized systems with limited support
Continuous improvement, LEAN manufacturing, problem solving, and/or Right First Time methodologies
Effective and strategic written and verbal communication skills including technical writing experience with investigations, change requests, standard operating procedures, protocols, etc.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s 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 office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining 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”.
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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day, 3rd - Night
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
10/17/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
