Deviation Management Specialist (GMP) – 37141 Position Available In Orange, New York

Job Description:

Job ID:

37141

Location:

West Point, PA 19486 (

Hybrid:

3 daysonsite)

Duration:

12 months

Shift:

Mon-Fri, 8:00 AM – 5:00 PM •

Pay Rate:

$46/hr.

Benefits:

Paid sick days, 401k, Discounted healthinsurance

Qualifications:

B.S./M.S.

degree in appropriateengineering/scientific field

• Minimum of 0-3 years post-Bachelor’sdegree experience in a cGMP environment (e.g. Production,Development, Process Engineering, Technical Services or relatedfield) in pharmaceutical/ biotech industry
• Previous experience inwriting investigations for atypical events in a manufacturingenvironment
• Familiar with Lean Six Sigma Methodologies and provenanalytical/ problem solving capabilities
• Demonstrated ability ofmeeting goals/timelines/organizational skills
• Excellent writtenand verbal communication skills
• Demonstrated ability to work bothindependently and as a part of a cross-functional team
• Preferableskills-Environmental monitoring experience, Formulation and fillingexperience, Line manufacturing experience (project engineer,maintenance and facility engineer, Experience in Bulk/Drugsubstance Manufacturing).

Responsibilities:

Primaryresponsibilities include day-to-day technical support tomanufacturing operations, including resolution and reduction ofprocess deviations, development and implementation ofcorrective/preventative actions, and leading manufacturinginvestigations

• This individual will be responsible for providingscientific support for manufacturing areas within Merck’sManufacturing Division (MMD)
• This Individual will also developworking relationships with counterparts in other areas supportingaseptic manufacturing, testing, planning, and release and isrequired to utilize sound scientific and engineering principles toinvestigate process deviations
• Troubleshooting and root causeanalysis of laboratory test failures and manufacturing atypicalevents, development of corrective/preventative actions is required
• Analysis of complex problems through critical analytical thinking
• Off-shift work may be required Comments/Special Instructions Briefteam meeting.

Assign investigations. Work on investigations(interviewing others, write-up at desk, SAP data mining). 80%Desk/20% meetings Position is typically Hybrid- 3 days on-site/2days remote after fully trained. Will be more on-site initiallyuntil trained Top Skillsets- Technical Writing/investigationexperience. Demonstrated capability of meetinggoals/timelines/organizational skills (Project Manager skillsets)Regards, Vinay Shastri Senior Associate –

PharmaceuticalRecruitment Phone:

1 609 681 2410

Email:

vinay.shastri@freyrsolutions.com 150 College Road West, Ste 102,Princeton, NJ 08540 www.freyrsolutions.com LinkedIn Profile