Job Description

Seeking candidates for a specialist position in the company's Research Laboratories (Research Division) Biologics Pilot Plant (BPP) supporting the Biologics Support Operations (BSO) Front-Line Managers.  The candidate will work under the director in a dynamic environment supporting compliance and operations objectives in aid of multiple pilot-scale campaigns for the GMP manufacture of bulk biologic (vaccines and therapeutic proteins) clinical supplies. Candidate will specifically support areas focusing on media and buffer manufacture, raw material weight and dispense, sterile tubing assembly and packaging, and GMP cleaning activities.

Tasks:

Candidate will participate in a range of activities including, but not limited to:

• Participate in or manage Quality Notification investigations and change management activities

• Order process consumables used in GMP manufacturing activities

• Submit requests for supply chains to Third Party Quality Management.

• Research and manage supplier notifications at the direction of the supplier notification lead.

• Prepare, Review, and update GMP Documentation (i.e. Standard Operating Procedures, Bills of Materials, Batch Records)

• Content expert and trainer for select procedures

• Data entry and electronic log creation and management

• Assist with PAS-X administrative work (i.e. parameter value list (PVL) updates/ Change Controls/ Manufacturing Order (MO) creation, coordinating QA approval)

• Assist with warehouse coordination (i.e. scheduling sampling, risk release management, deliveries, SAP management)

• Assist with equipment troubleshooting and calibration coordination

• Work with team members in identification and implementation of continuous improvement initiatives

• This is a developmental role with an opportunity to build a foundation into a front-line manager position. 

• Some overtime (including weekends) and occasional second shift work may be necessary. Carrying an on-call phone to support off-hour manufacturing will be required.

• Support safety, compliance, and GMP initiatives including conducting area walkthroughs and managing/closing observations

Experience/Skills:

• Comprehension of the regulatory guidelines governing GMP manufacture is required.

• The candidate will work in a team atmosphere in close partnership with (but not limited to) raw material release teams, facility operations, equipment engineering, process operations, safety, manufacturing division and quality groups.

Education:

• BS/BA in Biological Sciences, Chemistry, Engineering or equivalent combination of education and experience

Qualifications:

• Knowledge of current GMP regulations

• Work both independently and in a team setting

• Demonstrated ability to manage multiple tasks and priorities

• Effective problem-solving skills

• Effective technical communication skills

• Good comprehension of Microsoft Office Applications, including SharePoint and Power Platform Tools

Preferred:

• Knowledge of PAS-X Manufacturing Execution System

• Knowledge of SAP and Ariba order system

• Knowledge of the Electronic Supplier Transparency Request system

• Knowledge of ETQ Reliance system for supply chain notifications.

• Experience working within a Union Environment

• Has worked in relevant manufacturing or processing (aseptic/sterile, bulk, solid oral dosage, packaging, etc.)

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.