Senior Process Engineer at Advanced Group in Cambridge, Massachusetts

Job Description:

OVERVIEW

We are currently searching for a skilled professional to join a well-known client's team as a Senior Process Engineer in Cambridge, Massachusetts. This cross-functional role will support the GMP compliant clinical manufacturing facility, manufacturing engineering, and various internal departments. Apply now to talk to one of our recruiters and learn more about this progressive career opportunity.

RESPONSIBILITIES

• Manage proper functioning and preventative maintenance of GMP equipment in the Oligonucleotide production plant


• Serve as assigned project point of contact for internal and external contract manufacturing organizations


• Provide Engineering support to internal and external GMP manufacturing


• Work with internal stake holders and external vendors for developing specifications for equipment


• Draft and execute commissioning/qualification protocols for new equipment


• Lead the equipment design changes per fit-for-purpose process requirements


• Assist in the development of P&IDs to the process specifications


• Diagnose production issues via root cause analysis and implement change controls/CAPAs


• Support process validation efforts


• Develop mass-balance and active-process engineering based on materials flow


• Collaborate with the Process Development and the MSAT teams to assist with process scale up


• Ensure regulatory, GMP standards, and internal quality compliance for all project work


• Maintain a safety-first approach to manufacturing and be compliant with the in-house EHS program

EXPERIENCE

• Minimum of 7 years of experience in GMP/clean room manufacturing environment required


• Detailed knowledge of methods and procedures used in the manufacture and quality control of APIs required


• Experience working with API associated equipment


• Understanding of compliance and GMP considerations


• Good organizational and analytical/technical problem-solving skills


• Excellent written and oral communication skills


• Proficient in Microsoft Office suite, including Project and Visio


• Knowledge of CAD or similar P&ID developing tools desired


• Travel required - up to 10%

EDUCATION

• Minimum of Bachelor's Degree in Chemical Engineering required


• Master's Degree preferred

To be a best-fit your strengths must include:

• Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.


• Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.


• Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.


• Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.


• Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.


• Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.


It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.


Apply Now