Manufacturing Senior Associate, SOP Technical Writing (JP9811)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
|
|
|
Job Description:
Job Title: Manufacturing Senior Associate, SOP Technical Writing
(JP9811) Location: Thousand Oaks, CA. 91320 (Hybrid, 50% onsite)
Employment Type: Contract Business Unit: Pilot Plant Downstream
Duration: 12 months with likely extensions and/or conversion to
permanent Posting Date: 3/28/2022 3 Key Consulting is hiring
Manufacturing Senior Associate for a consulting engagement with our
direct client, a leading global biopharmaceutical company. Job
Description: The Manufacturing senior associate is expected to help
own and execute SOP and MP revisions according to SOP revamp
project. Bin items, Corrective Action and Preventative Action Plans
and corrective verification items will also be paramount additions
to new SOP format. Responsibilities include, but are not limited to
the following: General: Working with peers and floor staff in
functional areas for the implementation of best practices,
streamlining of operations, and equipment handling into SOPs and
MPs Facilitation of cross-functional teams (internal and external
to the site) with the goal of achieving robust and detailed
standard operating practices Communication of project status to
Senior Leadership in multiple forums (as requested); maintaining
the metric reporting for project performance Partner
cross-functionally across the site to ensure maturity and execution
of robust SOPs and alignment opportunities Provide timely and
comprehensive progress of project scope and status updates to
senior management Build and present decision point summaries for
Senior Management review Help to identify and coordinate a team to
include all company key partners and subject matter experts vital
for roll out, and documentation adjustment process Lead teams to
identify unit op robust documentation strategies and easy ways of
getting data to the data lake by effectively utilizing previous
biotech experience and working with manager. Basic Qualifications:
Bachelor’s degree and 1-2 years of Manufacturing or Operations
experience, OR Associate’s degree and 4 years of Manufacturing or
Operations experience, OR High school diploma / GED and 7 years of
Manufacturing or Operations experience Preferred Qualifications:
Scientific degree in Life Sciences or Physical Sciences, Applied
Engineering or Manufacturing Technologies Biotechnology or
Pharmaceutical experience Some Project Management and/or Quality
Management skills and experiences Experience leading
cross-functional/site investigation teams in complex deviations
including determination of potential product impact, root cause,
and corrective and preventative actions Experience in working with
multiple, contending priorities in a fast-paced environment with
minimal direction Proven leadership traits Excellent communication
skills, both written and verbal (including technical writing and
presentations) with ability to collaborate productively with
technical and senior management staff Ability to solve complex
problems and make scientific risk-based decisions Experience
presenting to and interacting with representatives of regulatory
agencies Trackwise database experience Direct bulk and fill and
finish manufacturing experience Aseptic processing knowledge and/or
practical experience Competencies: Passion for Operational
Excellence Communications skills, both oral and written, including
presentation skills Interpersonal and facilitation skills necessary
to forge consensus among challenging client interests while
ensuring objectives are met Ability to tactfully negotiate and
positively influence peers and executive leadership Analytical
skills to identify potential improvement opportunitie s Why is the
Position Open? Supplement additional workload on team. Top Must
Have Skills: Strong technical writing skills and versed in
Microsoft office apps, SOP writing experience preferred. Some
biotech production experience preferred. Organization. Successful
candidate will show task oriented behavior in an organized fashion
to allow for efficient work flow. Working on production floor/ bio
tech/ lab experience Day to Day Responsibilities: SOP and
manufacturing procedure editing. Employee Value Proposition: Career
growth / experience Red Flags: No science or biotech education or
background A PHD candidate would be overqualified for this role
Interview process: Phone screen / WebEx with hiring manager We
invite qualified candidates to send your resume to
recruiting@3keyconsulting.com . If you decide that you’re not
interested in pursuing this position, please feel free to look at
the other positions on our website www.3keyconsulting.com/careers.
You are welcome to also share this opportunity with anyone you
think might be interested in applying for this role. Regards, 3KC
Talent Acquisition Team
Keywords: 3 Key Consulting, Anaheim , Manufacturing Senior Associate, SOP Technical Writing (JP9811), Science, Research & Development , Thousand Oaks, California
